303 Regulatory Guidelines Jobs - Page 6

Rubicon Research Limited is a rapidly growing pharmaceutical formulation company focused on developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. With a diverse product portfolio of over 250 SKUs spanning more than 70 product families, we have established marketing, sales, and distribution platforms in the US through our subsidiaries AdvaGen Pharma and Validus Pharmaceuticals. Our US FDA-inspected R&D facilities in India and Canada, along with manufacturing facilities in Maharashtra, India, equipped with various drug development and manufacturing capabilities, demonstrate our commitment to quality and innovation. As a Manager in Analytical Method Validation at Rubicon Research Limited, you will play a crucial role in overseeing end-to-end activities related to validation and documentation for various regulatory markets. Your responsibilities will include ensuring accurate documentation for analytical method validation, planning daily validation activities, coordinating with the Analytical Development team, reviewing protocols and reports, managing incidences, investigations, and change control processes, and ensuring compliance with quality management systems. Additionally, you will be responsible for training and supporting the Analytical Method Validation team, providing technical input for analytical data generation, addressing analytical issues, and preparing material budgets. Key Qualifications & Experience: - M. Pharm/M. Sc in Organic or Analytical Chemistry - Proficiency in handling instruments such as HPLC, GC, KF, IC, PSD, etc. - Familiarity with US, UK, EU, and ROW regulatory bodies - Experience with GDP and regulatory query handling In this role, you will need to demonstrate a strong understanding of regulatory guidelines, ensure compliance in the laboratory, provide technical training to team members, and review documents through the Document Management System (DMS) following the Quality Management System (QMS). Your expertise will be crucial in maintaining GLP standards, meeting regulatory and quality expectations, and ensuring that all analytical work is audit-ready to meet FDA standards. Please note that the candidate is expected to work in various shifts as required and may need to visit external sites based on project requirements. If you are passionate about pharmaceutical development, regulatory compliance, and analytical method validation, we encourage you to join our dynamic team at Rubicon Research Limited.,

As a Clinical Trials Assistant, you will play a crucial role in supporting various aspects of clinical trials. Your responsibilities will include assisting in site selection, initiation, monitoring, and close-out visits for clinical trials to ensure their successful implementation. It will be your responsibility to ensure that all clinical trials are conducted in compliance with the protocol, ICH-GCP guidelines, and regulatory requirements. You will be tasked with maintaining accurate and proper documentation of all trial activities and reporting findings effectively. Your role will also involve supporting data verification by meticulously comparing source data with Case Report Forms (CRFs). Effective communication with investigators and site staff will be essential to address and resolve any issues that may arise during the trials. In addition, you will be expected to assist in tracking project timelines and deliverables to ensure the smooth progression of the trials. It will also be necessary for you to attend training sessions regularly to stay updated with the latest regulatory guidelines and industry standards. This is a full-time, permanent position suitable for freshers who are looking to kickstart their career in the field of clinical trials. The benefits of this position include health insurance, paid sick time, and Provident Fund. The work location for this role is in person, providing you with a hands-on experience in the clinical trials environment.,

You will be responsible for providing analytical support for developmental projects/comparative dissolution projects received from client sites. This includes being an interface with contract laboratories, suppliers, customers, and peers to define and improve project performance and expectations. You will coordinate with CRO to ensure that projects are completed within the timeline. Additionally, you will design scientific experiments, monitor lab work, and recommend further investigations based on experimental results. Your role will involve the preparation of test methods, technical documents, protocols, and reports when necessary. It is crucial to record information accurately, retain records and raw data properly, summarize, interpret, review data, and draw conclusions. You will analyze dissolution data sets, troubleshoot instrument or method-related problems, and adhere to GMP/safety requirements. Key interaction areas will include Drug Product development, Reg. CMC/LOC, and Spec management. Knowledge of invitro dissolution testing, comparative dissolution testing, statistical evaluation, and DoE is preferred. Familiarity with Regulatory Guidelines on dissolution studies such as FDA-SUPAC and ICH for validations and other emerging markets like China and Latin America is essential. Qualifications: - Masters in pharmacy or related science degree (or equivalent); or advanced degree (e.g., PhD) as applicable - Proficiency in English and/or other languages as required Experience: - 10-12 years of experience in the analytical field is desirable - 7-9 years of relevant industrial experience in Analytical science/Formulation science/material management and overall drug development and manufacturing process - Strong verbal, written, and presentation skills - Leadership capabilities with attention to detail and multi-tasking skills - Ability to interact and influence with various stakeholders - Experience in coaching project team members - Strong attention to deadlines and budgetary guidelines - Knowledge of medical and drug terminologies, GxPs, and worldwide regulatory requirements - Familiarity with ICH guidelines Preferred Qualifications: - Masters in Pharmacy or related science degree with 7-9 years of experience in formulation or Analytical development - Knowledge of data management systems, pharmaceutical product life cycle, and Management Information System (MIS) - Experience in DoE and statistical expertise - Diploma or certification in Regulatory Affairs Work Environment: - Office based For more information on Equal Employment Opportunity (EEO) and Accommodations, please refer to our policies.,

As a Senior Wealth Manager, you will be responsible for guiding high-net-worth individuals and institutional clients in managing and growing their wealth. You will develop personalized financial plans, manage investment portfolios, and provide guidance on tax strategies, risk management, and estate planning. With your expertise in market analysis and a deep understanding of clients" goals, you will offer comprehensive financial advice to optimize wealth growth and achieve long-term financial success. Key Responsibilities: - Managing and growing a client base focused on HNI/UHNI and affluent retail segments. - Driving sales of equities, mutual funds, insurance, and third-party investment products. - Delivering tailored financial advisory services aligned with clients" risk-return objectives. - Meeting and exceeding revenue/sales targets through cross-selling and retention strategies. - Providing portfolio allocation planning and suggesting alternate investment avenues (AIFs, structured products). - Staying current on market trends, regulatory changes, product offerings, and the competitive landscape. - Building long-term relationships and offering high-touch client servicing across offline and digital channels. Ideal Candidate Profile: The ideal candidate will have a strong track record in wealth or investment advisory roles, preferably working with affluent clients. You should possess excellent sales and interpersonal skills with a consultative relationship management approach. A deep understanding of equity markets, mutual funds, insurance, and structured products is essential. Familiarity with wealth management tech platforms and comfort collaborating with digital and operations teams is preferred. High standards of professionalism, discretion, and client confidentiality are expected. Required Skills and Qualifications: - Bachelor's degree in finance, economics, business administration, or a related field. - 6 months to 2 years of experience as a wealth manager or in financial services, including knowledge of developing and implementing financial plans and managing investments. - Understanding of financial markets, investment products, and wealth management principles. - Proficiency in financial analysis tools, portfolio management software, CRM systems, and the MS Office suite. - Excellent interpersonal skills and the ability to build trust and rapport with clients. - Strong analytical and problem-solving abilities with quick decision-making and a results-oriented mindset. - Exceptional verbal and written communication skills in explaining complex financial concepts to clients. - Integrity, ethical conduct, and adherence to regulatory guidelines and industry best practices. If you meet the qualifications and are interested in this opportunity, please drop your CV at shivangi08052025@gmail.com. Local candidates from Pune are highly preferred, and immediate joining is available.,

As a Lead QMS at Ai Health Highway, you will play a crucial role in implementing Quality Management System (QMS), ISO13485, EU MDR, and US FDA (510k) Risk Management processes for our cutting-edge medical devices. Your responsibilities will include creating device master records, updating technical documentation, and collaborating with internal and external stakeholders to establish a robust quality management and regulatory framework for our product pipeline. You will work closely with engineering and manufacturing teams to develop verification test strategies to ensure the safety and reliability of our products. Additionally, you will be involved in developing product requirements, supporting validation programs for new product development, and providing inputs for regulatory guidelines and procedures. Your expertise in risk assessment for medical devices, as per ISO13485/ISO 14971 CE certification, will be essential in this role. You will also be responsible for reviewing device labelling and advertising materials for compliance with regulations, liaising with external consultants, and assisting in documentation preparation for US FDA (510k) and EU-CE Marking regulatory submissions. To be successful in this position, you should have 3 to 5 years of experience in the Medical Device QMS and regulatory domain, along with a BTech/BE in Electronics/Electrical/CS or Bio-Medical Engineering. Strong skills in documentation, review, reporting, and excellent interpersonal communication are required. Experience in managing non-conformance, corrective action preventive actions, deviation, and conducting QMS training will be beneficial. Join us at Ai Health Highway in our mission to reduce premature deaths due to Non-Communicable Diseases by 30% by 2030. Your expertise and dedication will contribute significantly to our goal of revolutionizing healthcare with innovative medical devices.,

The role of Instrument Calibration Technician involves performing and documenting calibration of instruments and equipment at a pharmaceutical site to ensure compliance with cGMP, regulatory guidelines, and customer requirements. It is crucial to maintain accuracy and compliance standards to support pharmaceutical production and quality. Responsibilities include conducting on-site calibration of various process control instruments such as temperature sensors, pressure gauges, flow meters, humidity and temperature data loggers, weighing balances, and others. Calibration must be carried out following approved SOPs, master schedules, and work instructions. Collaboration with Quality and Engineering departments is essential to ensure access and compliance. Proper documentation and generation of calibration certificates/reports in accordance with regulatory norms like 21 CFR Part 11, cGMP, WHO, and NABL are required. Adherence to site-specific safety, gowning, and documentation protocols is mandatory. As an Instrument Calibration Technician, you will be responsible for identifying out-of-tolerance conditions and recommending corrective actions. It is crucial to ensure the traceability of standards used, which must be NABL-certified or equivalent. Updating calibration status stickers and logs at the instrument locations and supporting internal and external audits are part of the job requirements. This position is full-time, permanent, and suitable for fresher candidates. The benefits include Provident Fund. The work schedule may involve day shifts, morning shifts, and night shifts. The work location is in person. The application deadline for this position is 07/08/2025.,

We are seeking skilled and dedicated individuals to join our Quality Assurance (QA) department at Fido Pharma Private Limited, an esteemed pharmaceutical company located at Plot No: 108-109, Global Industrial Park, Mauli, Barwala, Panchkula, Haryana. If you have a background in B.Pharm / M.Pharm / M.Sc. and a passion for ensuring quality in pharmaceutical products, we have the following positions available: QA Manager: As a QA Manager, you will lead our Quality Assurance department, overseeing adherence to GMP and regulatory guidelines such as EU-GMP and WHO-GMP. Your responsibilities will include managing document control, validations, change control, Vendor Qualification, CAPA, deviations, and internal and external audits. You will be the main point of contact with regulatory bodies during inspections, ensuring timely compliance. Additionally, you will be responsible for developing and maintaining the company's quality systems and risk management strategy. Strong knowledge of cGMP, ICH, and regulatory requirements is essential for this role. Excellent communication, team management, and problem-solving skills are required. Previous experience in regulated manufacturing environments is preferred. Assistant Manager - Quality Assurance: In the role of Assistant Manager, you will provide support in managing and executing the site's quality systems, including change control, deviation handling, market complaints, and CAPA monitoring. You will assist in conducting periodic quality reviews and risk assessments and review batch documentation for accuracy and completeness. Internal audits, compliance activities, training sessions, and vendor qualification processes will also be among your responsibilities. A background in B.Pharm / M.Pharm / M.Sc. and 5-10 years of relevant experience are required for this role. Executive - Quality Assurance: As an Executive in the Quality Assurance department, you will be involved in line clearance and in-process quality assurance activities. Your duties will include maintaining documentation, supporting regulatory compliance, conducting internal audits, and assisting in vendor qualification processes. You will also participate in investigations of deviations, training programs, and vendor audits. Reviewing executed BMRs/BPRs, process control charts, and release documents will be part of your daily tasks. A background in B.Pharm / M.Pharm / M.Sc. and at least 1-6 years of experience are necessary for this role. If you are detail-oriented, proactive, and passionate about ensuring quality standards in the pharmaceutical industry, we invite you to apply for one of these exciting positions at Fido Pharma Private Limited. Join our team and contribute to the continual improvement of our quality systems and processes.,

You are invited to apply for the position of "Senior Relationship Manager-MMG" in a renowned bank located in Bangalore. As a Senior Relationship Manager, you will be responsible for sourcing New to Bank (NTB) clients in the mid and large corporate segment with turnovers ranging from Rs. 250 crores to Rs. 5000 crores. Your role will involve establishing and leveraging contacts with promoters, CEOs, CFOs, and Heads of Treasury across diverse industries such as Pharma, textile, auto, steel, FMCG, agriculture, retail, Infrastructure, chemicals, power, dairy, cement, and paper, among others. Your duties will also include resolving queries from the risk team and facilitating the entire process to ensure a quick Turnaround Time (TAT) of Credit Appraisal Memo (CAM). Additionally, you will be tasked with monitoring the asset portfolio, identifying potential risks, and ensuring timely account exits. A strong understanding of compliance, regulatory guidelines, and legal procedures set by entities like RBI, SEBI, and other sectoral regulators will be essential for this role. To be considered for this position, you must hold a Bachelor's or Post Graduate degree with 4-8 years of relevant experience in the Mid Market and Large corporate market. Your skills should encompass expertise in sourcing NTB clients, maintaining a robust network with industry leaders, efficiently resolving queries, demonstrating monitoring and risk assessment abilities, and possessing knowledge of compliance and regulatory frameworks. Preference will be given to candidates with experience across various industries such as Pharma, textile, auto, steel, FMCG, agriculture, retail, Infrastructure, chemicals, power, dairy, cement, and paper. If you meet these qualifications and are eager to take on this challenging role, we encourage you to submit your application for consideration.,

Join UAE's largest bank and one of the world's largest and safest financial institutions. The focus is on creating value for employees, customers, shareholders, and communities to grow through differentiation, agility, and innovation. The organization is looking for top talent, where your success is considered the organization's success. Accelerate your growth by helping to reach goals and advance your career. Be prepared to make your mark at a top company in an exciting and dynamic industry. To perform all functions of Trade Finance, Cash Management, Corporate Loans and Deposits, Borrowing, and settlement from the group while adhering to related regulatory guidelines and internal processes. Key responsibilities include processing all Global Transaction Banking (GTB) and Corporate Loans such as Working Capital Loans, Short Term Loans, and Deposits within the agreed TAT, organizing funds from the Head office ALM for lending to customers, processing Borrowing and settlement transactions, managing Deposit requests, and ensuring compliance with regulatory and internal guidelines and policies. Specific accountabilities include processing client requests within the agreed TAT for Trade, Cash, Corporate Loans, and Deposits, organizing borrowing from group ALM for onward lending, settling all transactions, ensuring compliance with FEMA regulations, internal guidelines, and policies, timely submission of regulatory returns, achieving a clean audit rating, performing KYC, AML & Sanctions related checks on all Trade Transactions, processing cash management products, participating in new product launch initiatives. Qualifications required: - Post Graduate MBA or CA - Minimum of 10 years experience in handling Loans, Trade Finance & Deposit products - Good knowledge of FEMA and ICC Regulations - Experience of working on various RBI applications - Excellent oral and written communication skills - Preferably CITF/CDCS certification Function within the framework and boundaries of Group policies, RBI Regulations, as well as the overall Organizational and Governance framework. Authorized to take decisions as per the approved Authorization matrix.,

Amgen is dedicated to leveraging the power of biology and technology to combat the most challenging diseases worldwide, while enhancing the quality and longevity of people's lives. For over 40 years, Amgen has been at the forefront of the biotechnology industry, utilizing cutting-edge innovation, technology, and genetic data to expand beyond current boundaries of knowledge. As the Scientific Communications Therapeutic Area (TA) Lead at Amgen, you will be responsible for overseeing the planning, resource management, and implementation of scientific communications deliverables, including medical content and publications, for a specific disease area or key product(s) within the assigned Therapeutic Area. Reporting directly to the Scientific Communications Head in India, you will collaborate closely with global and US scientific communication and medical leads to drive the tactical planning and execution of comprehensive scientific communication plans that align with overall product strategies. In addition, you will work in collaboration with Global and US/Regional Medical planning teams, Scientific Communication Operations team, and cross-functional capability teams to ensure process alignment, standardization, continuous improvement, and innovation, incorporating digital and multi-channel approaches. Your role will involve leading high-performing and engaged teams to exceed expectations. Responsibilities include leading the Scientific Communication team in Amgen India across the designated Therapeutic Area portfolio, recruiting, retaining, developing, and motivating staff, overseeing talent management and succession planning, fostering the Amgen culture, allocating resources effectively to meet product strategy/planning needs, ensuring compliance with relevant SOPs and processes, developing and monitoring Key Performance Indicators (KPIs), and collaborating with various internal teams to support training programs and the evolution of scientific communication processes. To qualify for this role, you must possess an advanced scientific degree (Doctorate degree/Master's/Bachelor's in Science) with at least 18-23 years of experience in the Pharma Industry. You should also have 4 years of experience in Global Publication, Medical Communications, Medical Value and Access, or Medical Strategy, along with 4 years of managerial experience directly managing people or leading teams, projects, programs, or resource allocation. Preferred qualifications include an understanding of the pharmaceutical commercialization process, knowledge of regulatory and legal guidelines affecting prescription product promotion, experience with multi-channel scientific platforms, proficiency in scientific and clinical data analysis and communication, familiarity with publication guidelines and transparency standards, and a track record of strategic execution in a matrix environment. Additionally, soft skills such as strong communication, ability to work effectively in global teams, initiative, self-motivation, project management, and adaptability will be beneficial for this role. Amgen is committed to providing reasonable accommodations for individuals with disabilities during the job application process, interviews, essential job functions, and other employment-related privileges. Please reach out to us to request any necessary accommodations.,

You will be responsible for screening and sampling activities in Consumer Bank - Retail Asset(s), as well as pre and post-verification activities. Your role will involve managing a team and vendors to drive field-level initiatives, activities, and enquiries. Additionally, you will be handling MIS and bill processing for respective vendors. It is expected that you take additional initiatives and be willing to travel outside the base location. As part of your duties, you will assess credit reports, credit scores, and other relevant financial data to determine creditworthiness. You must ensure compliance with internal policies and external regulations governing mortgage lending. To be considered for this role, you should have a minimum of 3 years of experience in KYC verification and a strong knowledge of regulatory guidelines, bank policies, and processes. A thorough understanding of retail asset products, processes, and business requirements is essential. You should also have the capability to pre-empt possible violations of controls/processes across Retail Assets. Proficiency in MS-Office for MIS preparation, good analytical skills, and excellent written and oral communication skills are also required.,

The ideal candidate for this role should possess a minimum education qualification of M. Pharmacy. You will be responsible for handling regulatory activities such as CTD dossier preparation, query resolution, and ensuring compliance with ICH guidelines and current regulatory standards. Your primary market focus will be on the Africa market, specifically in regions like Zazibona, South Africa, East Africa (Kenya, Tanzania, Ethiopia, etc.), and FWA. Your key responsibilities will include: - Preparation and submission of new dossiers - Conducting gap analysis of dossiers for completeness - Compiling dossiers in eCTD format for submission to various regulatory authorities - Coordinating dossier submissions in different countries - Evaluating and responding to queries, including coordination with manufacturers and final compilation of responses - Managing post-approval activities such as product lifecycle management, variations, and renewals - Monitoring harmonization of dossiers, queries, and variations across all countries - Developing artworks and obtaining approvals as per standard operating procedures - Engaging in daily communication with internal departments and external stakeholders - Updating trackers for queries and variations regularly - Attending unit and regional meetings, trainings, and other relevant sessions as required by the line manager and Intellectus Campus. Your role will require strong technical expertise in regulatory affairs, excellent communication skills, attention to detail, and the ability to manage multiple tasks while ensuring deadlines are met. Your proactive approach to problem-solving and ability to collaborate with various stakeholders will be crucial for success in this position.,

As a Training Manager for Micro Business Loans, you will be instrumental in driving the successful implementation and growth of the First Step Micro Business Loan product. Your main focus will be on providing comprehensive training to the bank's retail staff, ensuring they have the knowledge and skills needed to effectively promote, sell, and service this specialized loan offering. By collaborating closely with the retail team, you will contribute to business expansion and enhancing customer experience. Your responsibilities will include designing, developing, and delivering training programs for various retail staff members such as branch managers, relationship managers, and sales executives. You will ensure that the training content aligns with the unique features, benefits, and eligibility criteria of the First Step Micro Business Loan. Topics covered will include loan features, credit assessment, documentation, loan disbursement process, and customer engagement strategies. To deepen the understanding of retail staff regarding the First Step Micro Business Loan product, you will conduct regular workshops, webinars, and classroom sessions. Addressing queries, clarifying doubts, equipping sales teams with effective selling techniques, and collaborating with sales leadership to create specific sales playbooks and scripts will also be part of your responsibilities. Monitoring sales performance metrics, ensuring compliance with regulatory guidelines, and conducting periodic assessments are crucial aspects of your role. You will stay updated on industry trends and changes in lending regulations, work closely with branch managers and regional heads to drive loan origination targets, and foster a collaborative environment where best practices are shared. Collaboration with marketing teams for promotional campaigns, monitoring training program effectiveness, generating reports on training completion, and identifying areas for improvement will also be key responsibilities. Your qualifications should include a Bachelor's degree in Engineering, Technology, Management, Computers, or Science, along with an MBA. A minimum of 5 to 10 years of experience in retail banking, preferably with exposure to lending products, is required. Excellent communication, presentation, and interpersonal skills, as well as the ability to adapt training methods to different learning styles and levels of expertise, are essential for success in this role.,

You will be part of a team at Perceptive that is dedicated to revolutionizing the landscape of clinical research in the biopharmaceutical industry. Together, we strive to expedite the process of bringing crucial medical treatments to the market, contributing to faster advancements in healthcare. As we embark on this mission to make a significant impact on the world, we are looking for individuals like you to join us. In addition to the intrinsic job satisfaction you will derive from being a part of this transformative journey, we offer a comprehensive benefits package that includes: HEALTH: - Comprehensive medical plan coverage for you and your dependents. - Personal Accident Insurance for unforeseen circumstances. - Life Insurance to provide financial security for your loved ones. - Critical illness cover for additional protection. WEALTH: - Competitive salary structure and Flexi basket for financial flexibility. - Provident fund contribution of 12% to secure your future. - Gratuity scheme to reward your dedication and commitment. YOURSELF: - Access to internal growth opportunities and development programs. - Engage in specialized trainings to enhance your skills and knowledge. Your responsibilities will include: - Performing initial and technical quality review of medical imaging such as PET, SPECT, MRI, or CT. - Conducting imaging data reconstruction and processing efficiently. - Completing quality control (QC) documentation in compliance with good clinical practice and regulatory guidelines. - Generating queries to address discrepancies or issues effectively. - Collaborating with cross-functional groups within the Core Lab to uphold high standards of data collection and ensure successful project deliverables. At Perceptive, we celebrate diversity and individuality. We encourage you to bring your authentic self to work and embrace our inclusive culture. Join us as you are, and together, let's drive positive change in the field of clinical research.,

Job Description: As the Director of Safety Writing at GSK, you will be leading the safety writing team to ensure the accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans. Your role will involve a deep understanding of regulatory guidelines, effective leadership skills, and the ability to build a best-in-class capability to achieve organizational business goals related to safety writing. You will oversee the efficient preparation of high-quality safety writing deliverables that are strategically aligned and lead a global team of medical writers. Additionally, you will be responsible for optimizing internal and external resourcing, ensuring compliance, implementing best practices, fostering innovation, streamlining processes, and upholding standards of medical writing. Collaboration with the Head of Medical Writing to develop and drive departmental strategies will also be a key aspect of your role. Your leadership will be instrumental in aligning safety writing capabilities with business and operational needs, working closely with cross-functional safety teams for project clarity, and delivering high-quality safety documents that meet regulatory standards. Key Responsibilities: - Take accountability for all safety writing deliverables produced by the Medical Writing function. - Lead change initiatives to operate at the forefront of operational excellence. - Manage and lead line reports, including aspects of personnel management such as hiring, training, professional development, performance evaluations, compensation recommendations, promotions, teambuilding, and supervision of adherence to departmental procedures and health authority regulations. - Define and execute recruitment strategies to attract top talent. - Incorporate organizational considerations into strategic and operational decisions. - Create a compelling future vision and ensure it is measurable and aligned with organizational goals. - Demonstrate a track record of quality decision making and innovative problem resolution with significant operational impact. - Lead initiatives for process improvement, training, quality enhancement, and compliance. - Act as an industry thought leader, providing consultancy in areas like process improvement, pharmaceutical standardization, and implementation of regulatory guidelines. - Cultivate beneficial partnerships with external organizations to meet company objectives. - Oversee the identification and engagement of third-party partners, ensuring their performance and compliance meet business requirements. Basic Qualifications and Experience: - Minimum requirement of a master's degree in Life Sciences/Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.). A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine with patient exposure in a hospital-based setting is advantageous. - A total of 18+ years of experience, with at least 10 years in safety writing within the pharmaceutical industry or a large Contract Research Organization, demonstrating leadership skills. Ideal candidates will have expertise in applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing, serving as an internal and external safety writing expert. - Experience working in matrix/multicultural environments and diverse settings, especially within hybrid teams. - Strong negotiation skills for proposing creative solutions to new challenges. - Strategic acumen with robust planning and organizational capabilities. - Proficiency in both written and spoken English. - Ability to mentor and discern essential information, ensure logical flow, clarity, accuracy, and appropriateness for target audiences, such as regulatory authorities. Inclusion at GSK: At GSK, we are committed to inclusion and encourage candidates to reach out if they require any adjustments during the recruitment process. Contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs. Why GSK: GSK is a global biopharma company focused on uniting science, technology, and talent to combat disease collectively. Our mission is to positively impact the health of billions of people and deliver sustainable shareholder returns. We value our people as the cornerstone of our success, striving to create an environment where individuals can thrive, grow, and contribute to our shared ambition of getting ahead of disease together. Important Notice to Employment Businesses/Agencies: GSK does not accept referrals from employment businesses/agencies concerning vacancies posted on this site without prior written authorization. It is essential for employment businesses/agencies to contact GSK's commercial and general procurement/human resources department for authorization before referring any candidates. Unauthorized actions by employment businesses/agencies will not be recognized as having consent or contractual agreement with GSK, and GSK will not be liable for any fees arising from such actions. If you receive unsolicited emails or job advertisements from email addresses not ending in gsk.com, please disregard them and notify us at askus@gsk.com for verification of the job's legitimacy.,

You will be working as a Branch Manager, Assistant Branch Manager, or Branch Sales Manager at Ahalia FinForex Limited, located in Kochi. Your primary responsibilities will include overseeing daily branch operations, managing branch staff, ensuring customer satisfaction, and achieving sales targets. You will also be responsible for maintaining compliance with regulatory requirements, managing loan processing, handling foreign currency exchange services, and promoting wealth management and insurance products. Additionally, you will need to provide regular reports to higher management and contribute to the strategic goals of the organization. To excel in this role, you should have experience in branch operations, managing staff, and customer relationship management. You must possess the ability to achieve sales targets and develop business strategies effectively. Knowledge of loan processing, foreign currency exchange, and money transfer services is essential. Familiarity with wealth management, equity broking, mutual funds, ticketing, travel, and insurance services will be advantageous. Strong communication, leadership, and organizational skills are key requirements for this position. Proficiency in compliance and regulatory guidelines is necessary to ensure smooth operations. Relevant industry experience or a background in financial services would be preferred. A Bachelor's degree in Finance, Business Administration, or a related field is desirable for this role.,

As a Post Graduate qualified professional, you will be responsible for monitoring operational and customer service related activities of the Customer Processing Center (CPC) at Standard Chartered Bank. You will ensure adherence to reporting schedules, escalate matters to superiors for advice, and oversee the speedy resolution of customer queries and complaints in accordance with laid down procedures and quality standards. Your role will involve monitoring day-to-day processing and customer service activities of the CPC to meet service standards, resolving customer queries, complaints, and service-related issues. Additionally, you will maintain data and statistics on team performance related to business standards and customer information. In terms of processes, you will provide trade-related services to customers within the agreed turnaround times as per the Service Level Agreement and productivity standards. It will be essential to ensure strict compliance with internal procedures in line with the standards laid down by the bank. To enhance productivity, you will organize workflow to achieve maximum efficiency, monitor team performance regularly, and implement measures to improve efficiency. Developing, training, motivating, and educating staff to enhance morale and performance will also be part of your responsibilities. Risk management will be a key aspect of your role, involving the monitoring of major risk issues and concentrations. You will direct remedial action where necessary, ensure proper functioning of day-to-day controls, periodic monitoring activities, and timely resolution of risk issues. Compliance with internal operating procedures, key control standards, and the bank's data confidentiality policy will be crucial. Governance will require ensuring compliance with all internal procedures, operational controls, and regulatory requirements. You will be responsible for the preparation and submission of returns within agreed time schedules, compliance with policies and procedures related to money laundering prevention, and implementation of group policies on KYC and code of conduct. Your interaction with key stakeholders will include internal departments like CB, CIB, BB, SME, FI, Treasury, IT, Technology, and other Trade CPCs, as well as external entities such as customers, regulatory bodies, auditors, other banks, and vendors. In alignment with Standard Chartered's values, you will be expected to display exemplary conduct, comply with regulatory and business standards, and lead to achieve the outcomes set out in the bank's Conduct Principles. Collaboration in identifying and resolving risk, conduct, and compliance matters will also be part of your role. By working at Standard Chartered, you will have the opportunity to be part of an inclusive and values-driven organization that celebrates diversity and supports continuous learning and development. The bank offers various benefits such as retirement savings, medical and life insurance, flexible working options, wellbeing support, and a continuous learning culture to foster personal and professional growth.,

We are a technology-led healthcare solutions provider driven by the purpose to enable healthcare organizations to be future-ready. We offer accelerated global growth opportunities for talent that is bold, industrious, and nimble. At Indegene, you will gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. If you are looking to explore exciting opportunities at the convergence of healthcare and technology, visit www.careers.indegene.com. Jump-start your career with Indegene where we understand the importance of the first few years in shaping your professional journey. We promise you a differentiated career experience working at the exciting intersection of healthcare and technology. You will be mentored by some of the brightest minds in the industry, offering a global fast-track career opportunity to grow along with Indegene's high-speed growth. We are a purpose-driven organization that enables healthcare organizations to be future-ready, with customer obsession at the core of our operations. Our actions are bold, decision-making nimble, and work ethic industrious. **Must Have:** - **Education:** MBBS/PhD/MDS/BDS/MPharm/PharmD - **Experience:** 4 to 6 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) - **Role Purpose:** Lead Medical Writer is responsible for the development and review of medical writing deliverables supporting the clinical regulatory writing portfolio and training junior writers. **Skills Required:** - Authoring various clinical document types supporting regulatory filings - Excellence in focused writing and editing following defined processes - Leading cross-functional teams to draft scientific/medical content - Understanding the clinical development process from program planning to submission - Effective time management, organizational, and interpersonal skills - Customer focus and ability to work independently while following structured processes - Ability to move across Therapeutic Areas to support business continuity - Develop, coordinate, and oversee work plans for multiple-document delivery - Facilitate review meetings, address feedback, and negotiate solutions **Knowledge Requirement:** - Strong scientific knowledge and understanding of regulatory guidelines - Ability to interpret data and apply scientific knowledge to support regulatory document writing - Manage messaging for consistency and alignment with the agreed-upon strategy - Comfortable working on cross-functional teams and providing insights based on previous experiences - Experience writing protocols, amendments, CSR, and CTD summary documents **Good to Have:** - Expert authoring in MS Word and understanding MS Word functionality - Experience working in document management systems and managing workflows - Flexibility in adapting to new tools and technology - Capable of training writers/authors on the use of templates, guidelines, and tools **Responsibilities:** - Prepare/review clinical study reports, protocols, investigator brochures, and submission data summaries - Apply lean authoring principles and coordinate document review activities under aggressive timelines - Develop and maintain project plans and work as an active member of cross-functional teams - Ensure adherence to standard content, lean authoring, and messaging across team members - Conduct literature searches and screening as needed - Share lessons learned, best practices, and ensure compliance with company training **Equal Opportunity:** Indegene is an equal opportunity employer dedicated to providing a diverse and inclusive workplace for all employees.,

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may independently provide timely and professional leadership of special projects that focus on innovative tools and systems. You will strategically and tactically support the Director Clinical Data Standards and be responsible for advising/leading the planning, development, and implementation of Industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. Your role will also involve providing expert support and stellar customer focus to business users and teams on their use of data standard collection tools, data transfer specifications, analysis data/TFL standards/Define, automation solutions/technologies, and business infrastructure, business rules, and guidelines. You may also lead global teams as required. At the study level, you will be responsible for all statistical tasks on assigned clinical or non-clinical trials, particularly for high complexity trials, seeking peer input/review as required. You will contribute to protocol development, statistical analysis plan development, and reporting activities. Additionally, you will provide statistical expertise to support submission activities and documents, meetings with Health Authorities, pricing agencies, and other drug development activities. You will independently lead interactions with external review boards/ethics committees, external consultants, and represent the organization in statistical discussions at external congresses, conferences, and scientific meetings. You will be responsible for strategic statistical input into one or more projects, collaborating with clinical, regulatory, and other strategic functions to drive quantitative decision-making in drug development. At the disease area/TA/indication level, you will drive strategic statistical input and excellence to development programs within the assigned areas. Additionally, you may lead or significantly contribute to initiatives at the global line function level or cross-functional franchise level, requiring coordination of diverse team members. You will actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives and represent the organization in due diligence teams for in-licensing opportunities. The ideal candidate will have an MS (in Statistics or equivalent) with 10+ years of relevant work experience or a PhD with 6+ years of relevant work experience. Strong interpersonal and communication skills, along with proven expertise in statistics and its application to clinical trials, are essential. Additionally, experience with statistical software packages such as SAS or R, and a strong understanding of drug development and Health Authority guidelines are required. The role may also require expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Novartis is committed to providing reasonable accommodation to individuals with disabilities. For more information or to request accommodation during the recruitment process, please contact [email protected] and include the job requisition number in your message.,

You will be working as a project manager in the Quality IT department of Piramal Pharma Solutions located in Kurla. As a project manager, you will lead the project team and play a key role as a Subject Matter Expert for the SAP S4-HANA- QM module. Your primary responsibilities will involve collaborating with internal stakeholders such as Operations, Manufacturing sites, Quality and operation team, and Business units including SCM, Finance, GBSS, HR, Admin, central Quality, and CMO team. Externally, you will engage with IT Vendors, IT Contractors/Consultants, and Customers. With 12 to 15 years of experience in the Pharma/Life Science domain, you will have a deep understanding of SAP ECC/SAP HANA system for the Quality Management (QM) module. It would be beneficial if you have worked in both IT and Pharma sectors, possess hands-on experience at manufacturing sites, and are familiar with quality and manufacturing processes. Additionally, experience in project management, team leadership, and strong communication, analytical, and customer service skills are required. Your role will include acting as a Business Process Manager, leading project teams for SAP ECC/SAP HANA system implementation, and providing SME support for Quality Management module integration. You will define project scope, manage project lifecycle, conduct project review meetings, coordinate with cross-functional teams, collaborate with IT departments, and ensure adherence to project management methodology practices. Travel within India or outside may be required for project-related work. Ideally, you should have a Graduate degree in Science/Pharmacy/Engineering with a Post Graduation in Science/MBA being desirable. Your competencies should include good verbal and written communication skills, knowledge and experience in SAP ECC QM module implementation, functional knowledge of regulatory guidelines, and hands-on experience in system configuration for the QM module. Additional certifications such as SAP QM Certification, PMP/Prince II certification, and experience in validation on automation/digitization projects will be considered a plus. In this role, you will stay informed about SAP QM module updates, industry trends, and make recommendations for system improvements. You will be responsible for tracking project performance, maintaining effective relationships with stakeholders, and ensuring project goals are met within the desired timelines. Your proactive approach to problem-solving and ability to suggest process improvements will contribute to the success of the projects. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. PPS serves customers globally through a network of facilities in North America, Europe, and Asia. The organization provides various services including drug discovery solutions, pharmaceutical development, clinical trial supplies, commercial supply of APIs, and specialized services like the development and manufacture of biologics. Operating under the core values of inclusive growth and ethical practices, Piramal Group ensures equal employment opportunities based on merit and qualifications.,

Join Amgen's Mission to Serve Patients If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together, researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. What You Will Do The Scientific Communications Senior Manager is accountable for planning and delivering innovative scientific and medical content aligned to their designated Therapeutic Area/product (General Medicine, Inflammation, Oncology, Rare Disease, or Obesity), tailored to specific audiences globally via impactful formats and relevant channels. Reporting to a Scientific Communications Therapeutic Area (TA) Lead in India, this leader manages a small team of scientific communication team members and drives the execution of tactical Scientific Communication plans for US and global regions to deliver our Medical and overall product strategies. The Scientific Communications Senior Manager may directly partner with US/Regional Medical planning team and Scientific Communication Operations team members to drive process alignment, standardization, and adoption of innovation and transformational change. This role is responsible for creating and leading high-performing and engaged teams to exceed expectations. Roles And Responsibilities - Develop and deliver high-quality, accurate, and innovative scientific and medical content (DSE/digital/MSL materials/FAQs/Medical Information Letters) tailored to specific audiences in the US and globally via impactful formats and relevant channels. - Publication-related deliverables (manuscripts/abstracts/posters/Oral presentations, enhanced content). - Addressing Medical Information inquiries/issues. - Maintain strong partnerships with Scientific Communication Operations team in support of standardization of processes, optimizing systems, and furthering continuous improvement and innovation, including the use of digital and multi-channel approaches, as well as definition of impactful KPIs. - Drive the execution of a comprehensive scientific communication plan that shifts based on changes in the disease area and treatment landscape and in-depth awareness of insights across local affiliates and cross-functional partners. - Ensure compliance with relevant Amgen enterprise and Functional SOP(s) and system(s). - Assist in recruiting, onboarding, and training of staff members. - Support prioritization process, prepare and oversee team assignments to meet program goals on time and within budget. - Develop, maintain, cultivate, and influence strong relationships with cross-functional colleagues. - Foster Amgen culture and motivate high-performing and empowered staff. What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications - Doctorate degree with a minimum of 10 years of experience in Global Publication, Medical Communications, Medical Value and Access, or Medical Strategy. - Masters degree with a minimum of 12 years of experience. - Bachelors degree with a minimum of 14 years of experience. - Minimum of 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Must-Have Skills - MD, PharmD, PhD, or DO with 4 or more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs, and/or basic research (other doctorate degrees may be considered). - Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or research in the therapeutic area. - An understanding of the pharmaceutical commercialization process and knowledge of the regulatory and legal guidelines affecting promotion of prescription products. - Experience in publication planning, publications guidelines, and transparency standards (e.g., ICMJE, current Good Publication Practice (GPP) Guidelines). - Understanding of Amgen focused disease area and landscape and clinical data to enable critical analysis of scientific literature and communicate implications cross-functionally. - Demonstrated track record of strategic execution in a matrix environment with limited supervision. - The ability to work in teams and interface in a dynamic environment across corporate functions. Preferred Skills - Knowledge of emerging technologies in medical communications (e.g., AI tools, omnichannel engagement platforms). - Strong computer and database skills, particularly with Microsoft Office products. Soft Skills - Strong verbal and written communication skills. - Ability to work effectively with global, virtual teams. - High degree of initiative and self-motivation. - Ability to manage multiple priorities successfully. - Collaborative mindset with a strong sense of accountability and ownership. - Ability to drive continuous improvement and adapt quickly in a fast-evolving environment. - Strong project management with the ability for self-direction. What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination. Objects in your future are closer than they appear. Join us. EQUAL OPPORTUNITY STATEMENT We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.,

As a Toxicologist / Preclinical Scientist at our organization, you will play a crucial role in conducting toxicological risk assessments and overseeing preclinical experimental research. Your responsibilities will include deriving health-based exposure limits, conducting toxicological risk assessments for various substances, performing genotoxicity hazard assessments, evaluating extractable and leachable impurities, and determining harmful doses for children. In addition, you will be involved in developing preclinical strategies, planning, overseeing, and interpreting in vitro and in vivo preclinical toxicology studies, pharmacokinetics/pharmacodynamics studies, biocompatibility studies for medical devices, and immunogenicity studies for peptides and biosimilar products. You will also be responsible for summarizing toxicological data and preparing regulatory submissions such as Investigational Brochures, Investigational New Drug applications, and electronic Common Technical Document for regulatory authorities. To qualify for this role, you should have an advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Medicine, or a related field, along with a minimum of 3-5 years of experience in toxicological risk assessment and experimental toxicology in the pharmaceutical, CRO, or biotechnology industry. You must possess a strong understanding of regulatory guidelines from organizations such as ICH, USFDA, EMA, CFDA, and DCGI, and have experience with regulatory submissions. Furthermore, you should demonstrate the ability to manage multiple projects simultaneously, work effectively in a dynamic team environment, communicate excellently, collaborate cross-functionally, and interact with external partners such as CROs. Being detail-oriented with proactive planning abilities, strong analytical skills, effective timeline management, adept problem-solving capabilities, and excellent collaboration and teamwork skills are essential for this role. Proficiency in using computer software including Microsoft Office suite, SharePoint, QSAR tools, data mining software, citation tools, and other relevant applications is required. This full-time position is based in Vikhroli, Mumbai, with general shift hours and rare/occasional travel for outdoor duties/monitoring.,

As a member of the QA Team, your primary responsibility will be to conduct food safety audits at all our outlets located in Bangalore and Mysore regions. Your key accountabilities will include planning and executing food safety audits in compliance with regulatory guidelines. You will be expected to manage your work plans efficiently to ensure timely completion of audits, including scheduling and workload management. Additionally, you will need to submit audit reports within one working day, summarizing the findings for review by the Head of Department (HOD) before sharing them with the retail team. Your role will also involve driving food safety and quality improvements to support business growth across our retail outlets. To excel in this position, you must hold a Bachelor's Degree in Food Technology or Microbiology. Completion of Fostac Training and HACCP certification is mandatory. Proficiency in typing, spreadsheet usage, word processing, and email communication is essential for successful performance in this role. The ideal candidate should possess excellent verbal and written communication skills, analytical capabilities, strong interpersonal abilities, and problem-solving skills. You must have a minimum of one year of professional experience and be willing to travel extensively across Bangalore and Mysore. This position requires 100% travel throughout the month. You will report to the Quality Head of QA & QC, and the job type is full-time. In addition to competitive compensation, the benefits package includes health insurance and provident fund coverage. Experience in auditing is preferred, and the work location is on-site.,

As a fresher joining our team, your primary responsibilities will include client acquisitions, conducting meetings, and ensuring timely follow-ups. It will be crucial for you to learn and understand clients" financial goals, risk appetite, and investment preferences to provide them with suitable investment options. You will also be supporting in explaining mutual fund products, their features, and regulatory disclosures to clients. Additionally, you will assist clients with account opening formalities, documentation, and basic servicing needs. Coordination with operations, compliance, and product teams to resolve client queries will be an essential part of your role. You will have the opportunity to shadow client calls and meetings to learn effective prospecting and relationship-building techniques. Identifying cross-selling opportunities and supporting relevant initiatives will also be among your responsibilities. Maintaining accurate records of interactions, leads, and service requests as per internal protocols will be expected. It will be essential for you to stay updated on mutual fund products, industry trends, and regulatory guidelines through regular training sessions. During your training period, the focus areas will include basics of mutual funds and financial planning, client communication and soft skills development, client and AP acquisition strategies, compliance and KYC documentation procedures, CRM and sales reporting tools utilization, as well as SEBI mutual fund regulations and distributor ethics. This is a full-time, permanent position with a work schedule from Monday to Friday and availability on weekends may be required. The work location will be in-person to ensure effective collaboration and communication within the team.,

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. You will follow SOPs/WIs, regulatory directives, study-specific plans, and guidelines. This position may involve database development and testing, as well as additional data management activities. Key responsibilities of the role: - Support the Lead DM as a backup or team member, ensuring continuity, responsiveness, and timely task completion - Perform data entry for paper-CRF studies and ensure quality control of data entry - Provide input into timelines, assess resource needs for projects, and ensure clinical data management deadlines are met with quality - Assist in developing CRF specifications from the clinical study protocol and coordinate review/feedback - Assist in building clinical databases and conduct database build UAT - Specify requirements for edit check types and maintain data management documentation - Train clinical research personnel on study-specific items as needed - Review and query clinical trial data according to the Data Management Plan - Perform medical coding of medical terms for logic and consistency - Assist with coordinating SAE/AE reconciliation and liaising with third-party vendors - Assist with SAS programming and quality control of SAS programs - Identify and troubleshoot operational problems and provide feedback on protocols and reports - Participate in the development and maintenance of SOPs related to data management - Communicate with study sponsors, vendors, and project teams regarding data issues - Present software demonstrations/trainings and participate in project meetings - Perform other assigned duties. Qualifications: - Minimum 4 years of experience in Data Management - Bachelor's degree in a scientific/science field with related experience - Proficiency in Microsoft Office tools - Strong organizational and communication skills - Basic knowledge of drug, device, or biologic development and data management practices Preferred qualifications: - Experience in a clinical, scientific, or healthcare discipline - Medical coding knowledge (MedDRA and WHODrug) - Understanding of CDISC standards - Oncology and/or Orphan Drug therapeutic experience Skills: - Strong knowledge of ICH-GCP, Precision Oncology SOPs, and regulatory guidance Competencies: - Motivates project team members and focuses on continuous improvement - Resolves project-related problems and prioritizes workload effectively - Demonstrates self-motivation and professionalism - Works well independently and in a team environment Precision for Medicine is a precision medicine CRO dedicated to advancing the science of precision medicine across various therapeutic areas. All data provided during the application process will be handled in accordance with the Privacy Policy. Applicants with disabilities requiring accommodations can contact Precision Medicine Group for assistance. Note: Precision for Medicine warns applicants about potential fraudulent offers and emphasizes that all job offers will involve communication with the recruiting team, hiring managers, and a formal interview process.,