1247 Regulatory Affairs Jobs

Immediate opening for Chemical and Pharma Industries Qualification - BE / B Tech / BSc / MSc - Chemistry / Chemical / Biotechnology / Biochemistry / Microbiology / Petrochemical Designation - Production chemist / Qc - QA / Regulatory Affairs / WTP / STP / ETP / Purchase location - chennai / coimbatore / Hosure Experience - Freshers ( pharma related Experience only apply ) Immediate Joining can contact Keerthana HR - 9384810696 ( call or watsapp ) Drop your resume to this mail id - hr02jjjobs@gmail.com Venue Details: JJ Jobs S2, 1/44,2nd floor , parvathi Apartment / Bazar road jj nagar , Mogappair East Chennai -37 Land mark- MMM hospital & Green park cafeteria website -jjjobs.co.in

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a diverse range of products and services to customers worldwide. The business is organized into two segments: Specialty Pharmaceuticals, which includes Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma, with Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, specializing in APIs and Dosage manufacturing, respectively. The Mysore manufacturing site, spread over 69 acres, is USFDA approved and focuses on manufacturing APIs for Lifestyle-driven Therapeutic Areas (CVS, CNS). It holds a leading market position in four APIs and is among the top three players for three other APIs. The Roorkee facility is a state-of-the-art site approved by multiple regulatory bodies like USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA, catering to EU, Canada, and emerging markets following a B2B model. Both manufacturing units are supported by approximately 500 research and development professionals based in Noida and Mysore. The R&D team focuses on developing new products, including APIs, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. Additionally, in-house BA/BE studies are conducted at an 80-bed facility with global regulatory accreditations. JGL's Regulatory Affairs & IPR professionals ensure a unique portfolio of patents and product filings in both regulatory and non-regulatory markets. The revenue of Jubilant Pharma has been consistently growing, reaching INR 53,240 Million during the Financial Year 2018-19 compared to INR 39,950 Million in 2017-18. For more information about the organization, please visit www.jubilantpharma.com.,

About Syngene: Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything you do personally and professionally. Safety is placed at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs in letter and spirit. It is mandatory for all roles at Syngene to adhere to safe practices and procedures, contributing to the development of procedures, practices, and systems that ensure safe operations and compliance to the company's integrity and quality standards. A corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline is to be driven at the workplace at all times. Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following EHS requirements is essential. Completing all assigned mandatory trainings related to data integrity, health, and safety measures on time by all team members, including self, is a requirement. Compliance with Syngene's quality standards and holding self and teams accountable for safety goals are crucial. Core Purpose of the Role: Responsible for overseeing the Regulatory Affairs function across Biocon Park, MN Park Hyderabad & MSEZ Mangalore facilities. The role ensures compliance with National regulations, supports strategic initiatives, and fosters Syngene's position as a trusted partner for clients and regulators. Role Accountabilities: - Develop and execute a forward-looking, risk-based regulatory strategy aligned with Syngene's business priorities. - Drive long-term relationships with regulators, advocating for policies that enable sustainable growth. - Identify and address inefficiencies in cross-business processes to strengthen regulatory operations. - Represent Syngene in regulatory inspections and audits, ensuring preparedness and successful outcomes. - Build and mentor a high-performing regulatory team with capabilities aligned to future needs. - Offer innovative solutions that align with both client and organizational goals. - Drive change management efforts that enhance cross-functional collaboration and operational excellence. Primary Responsibilities: - Develop and execute a risk-based regulatory strategy to mitigate compliance risks while supporting business goals. - Lead the development and implementation of regulatory policies, ensuring alignment with national standards and organizational objectives. - Proactively identify changes in regulatory landscapes and prepare the organization for future requirements. - Provide strategic guidance to project management and operations teams on regulatory planning and submissions. - Strategize and coordinate prompt submission of regulatory applications across sites & represent Syngene during regulatory inspections and audits, ensuring successful outcomes. - Provide consultation to internal stakeholders regarding national regulatory aspects as and when needed. - Implement and maintain processes, procedures, and trackers essential for national regulatory support function performance in the organization. - Provide prompt updates to stakeholders on licenses/permissions and participate in teleconferences/discussions with stakeholders/clients as required. - Train and mentor regulatory team members and stakeholders on compliance requirements, fostering a culture of excellence and continuous improvement. - Proactively anticipate changes in the regulatory landscape, developing strategies to address future requirements while safeguarding compliance. - Lead policy advocacy efforts, engaging with industry associations and regulatory authorities to represent Syngene's interests effectively. Leadership Capabilities: - Excellent English and Kannada language skills, both verbal and written. - Excellent communication skills. - Client Relationship Management, Team building, and leadership. - Analytical and reasoning skills. - Excellent awareness of regulatory requirements in the country. Syngene Values: All employees will consistently demonstrate alignment with our core values: - Excellence - Integrity - Professionalism Specific Requirements for this Role: Experience: 18+ years in regulatory affairs with proven success in leading teams and managing high-stakes regulatory challenges. Education: Advanced degree (masters or higher) in Pharmacy, Biological Sciences, or related fields. Certifications in Regulatory Affairs are highly desirable. Skills and Capabilities: 1. Reviewed submissions made to the regulators relating to import, export, development (R&D), manufacture, clinical development, post-approval changes, storage, disposal of drug substances and drug products (human and animal). 2. Other associated approvals, namely: biosafety, recombinant, narcotics, atomic energy related, agrochemical related, animal husbandry related, FSSAI related, and any other approvals as relevant. Equal Opportunity Employer.,

The primary responsibility of this role is to manage Regulatory Affairs in compliance with relevant regulations and guidelines for the organization. As a Regulatory Affairs Manager at DDReg, you will be involved in reviewing clinical, biopharmaceutical, non-clinical, and labelling documentation. Your duties will include preparing and reviewing non-CMC sections, Variations, site transfers, and conducting post-approval gap analysis. Additionally, you will support the regulatory function through document management, electronic submission compilation, and other group management activities as needed. Collaboration with various departments such as Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research and Development will be necessary to ensure regulatory compliance and operational excellence. Your responsibilities will involve providing high-quality reviews of CTD sections for regulatory filings to various regulatory authorities such as EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia, and other markets globally. You will actively contribute to developing and implementing regulatory strategies, processes, and timelines for global approval. Conducting Gap Analysis of Non-CMC sections, authoring and compiling CTDs sections, preparing labelling documentation, managing labelling changes, and ensuring compliance with regulatory guidelines will be key aspects of your role. Furthermore, you will be required to demonstrate expertise in regulatory matters, collaborate with internal and external stakeholders, and provide technical consultation and advice on strategy and industry best practices. To excel in this role, you should possess a Bachelor's or Master's degree in Pharma and have at least 5+ years of relevant experience in the pharmaceutical/CRO industry. Strong project management skills, excellent interpersonal and communication skills, and in-depth knowledge of global regulatory guidelines are essential for success. Proficiency in Microsoft Word, PowerPoint, and Excel, along with the ability to work effectively in a team-oriented environment, are also crucial requirements. The ideal candidate should be adaptable, capable of working under pressure, and able to deliver high-quality results within tight timelines. This position is based in Gurgaon, Haryana, India. Occasionally, you may be required to work across different time zones to fulfill job requirements.,

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization collaborating with global health and science authorities to establish quality standards for medicines, dietary supplements, and food ingredients. USP's core value of Passion for Quality is upheld by over 1,300 dedicated professionals across twenty global locations, working towards ensuring the supply of safe, quality medicines and supplements worldwide. Emphasizing inclusivity, USP values mentorship, professional growth, and a culture promoting Diversity, Equity, Inclusion, and Belonging for a world of quality healthcare assurance. As a Supervisor at USP, your primary responsibility is to lead the acquisition and submission of documentary standards from stakeholders in South Asia. You will also facilitate the procurement of materials from India donors for monograph development by Reference Standard (RSL) and Compendial Development laboratories (CDL). In this role, you will contribute significantly to USP's mission of enhancing access to high-quality, safe medicine globally. USP invests in the professional development of all managers, providing training in inclusive management styles to ensure a productive and engaged work environment. Key Responsibilities include: - Leading and managing monograph acquisition efforts in the South Asia Region. - Establishing contacts in India for acquiring standards, materials, and reference materials required for public standards development. - Supporting donor recognition efforts and guiding potential monograph sponsors through USP processes. - Delivering monograph materials to USP for further development by committees efficiently. - Identifying sources of free materials for efforts in CDL and RSL. - Mentoring donations staff on standards acquisition activities. Requirements: - Bachelor/Masters degree in Pharmacy/Life Sciences/Chemistry/Biological Sciences with a preference for a business management degree/MBA. - 9 years of experience for Manager Level with a technical background and customer-facing roles. - 12 years of experience for Sr. Manager Level with a technical background and customer-facing roles. - Basic understanding of pharmacopeia, compendial standards, and the pharmaceutical industry. - Proficiency in project management, use of KPIs, and business analytics. - Strong communication skills, ability to influence, results-driven, and adept at handling multiple priorities. Preferred Qualifications: - Experience in pharmaceutical, Analytical R&D, or bio-reagent industry. - Regulatory Affairs function experience and knowledge of project management. - Familiarity with Salesforce, Oracle EBS, and pharmaceutical market dynamics. - Ability to synthesize data, influence without direct authority, and work well in diverse environments. - Flexibility for travel and excellent written and verbal communication skills. Supervisory Responsibilities: - Associate Donations Manager, RPO India. USP offers comprehensive benefits to safeguard your well-being and that of your family, including time off, healthcare options, and retirement savings. Note that USP does not accept unsolicited resumes from third-party recruitment agencies. Frequent Contacts include internal stakeholders in USP India and USP-Rockville, as well as external contacts in the pharma industry, trade associations, customers, and stakeholders. Join USP in making a difference in global healthcare quality and standards.,

What you will do Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance. Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource. Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work. Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures. Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature. Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes. Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products. Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications. Determining and communicating submission and approval requirements. What you need: Required- Bachelor&aposs or Masters degree in Regulatory Affairs, Engineering or equivalent discipline is required. 3 - 5 years experience Preferred- Experience with post-market and change management is a distinct advantage RAC Certification is preferred Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Show more Show less

Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia, the Middle East, and the rest of Asia-Pacific. Recognized by Great Place to Work in India, Chile, Romania, the US, and the UK in 2022, we offer a dynamic, growth-oriented, and meritocracy-based culture that prioritizes continuous learning and skill development, work-life balance, and equal opportunity for all. Curious to know what its like to work at Evalueserve? Read on. About Investment Research (IR) As a global leader in knowledge processes, research, and analytics, youll be working with a team that specializes in global market research, working with the top-rated investment research organizations, bulge bracket investment banks, and leading asset managers. We cater to 8 of the top 10 global banks, working alongside their product and sector teams, supporting them on deal origination, execution, valuation, and transaction advisory-related projects. What you will be doing at Evalueserve Work directlywith the head of the team, who has been consistently ranked as the top analystin CEEMEA strategy by several top-tier investment banks. Handle research, strategy, and analytics for all EM fixed income-related products offered by theresearch platform of the banking client. Conduct macroeconomicand market research across emerging markets. Develop andmaintain financial models and analytical frameworks for EM fixed incomeproducts. Analyze largedatasets to identify market trends and investment opportunities. Support theteam in producing high-quality research reports and market commentary. Collaboratewith trading, sales, and risk teams to align strategy insights with businessneeds. Utilize toolssuch as Bloomberg, Macrobond, and Haver, and IMF databases for data extractionand analysis. What were looking for: Advanceddegree in economics /statistics /engineering with minimum relevant experienceof 3 years. Progress towards CFA / FRM is preferable. Priorexperience of macro research, financial modeling, structuring, trading, ormarket risk management Keen interestin global financial markets and knowledge of recent developments. Strongquantitative and mathematical skills with experience of working with largeamounts of data. AdvancedExcel, VBA analytical skills, and knowledge of basic econometrics is a must.Working knowledge of Python or R will be considered a plus. Excellentwritten and verbal communication skills ability to write research reports andcomment on market developments. Knowledge ofdatabase tools Bloomberg, Macrobond, Haver, World Bank, IMF, etc. Follow us on https://www.linkedin.com/compan y/evalueserve/ Click here to learn more about what our Leaders talking on achievements AI-powered supply chain optimization solution built on Google Cloud. How Evalueserve is now Leveraging NVIDIA NIM to enhance our AI and digital transformation solutions and to accelerate AI Capabilities . Know more about how Evalueserve has climbed 16 places on the 50 Best Firms for Data Scientists in 2024! Want to learn more about our culture and what its like to work with us? Write to us at: careers@evalueserve.com Disclaimer: The following job description serves as an informative reference for the tasks you may be required to perform. However, it does not constitute an integral component of your employment agreement and is subject to periodic modifications to align with evolving circumstances. Please Note: We appreciate the accuracy and authenticity of the information you provide, as it plays a key role in your candidacy. As part of the Background Verification Process, we verify your employment, education, and personal details. Please ensure all information is factual and submitted on time. For any assistance, your TA SPOC is available to support you.

Description Regulatory Manager (CMC, EU & Japan/China) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http:// syneoshealth Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job, Show

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota; 1.5% of incentive target for each 1% of attainment between 50% and 75%; 1% of incentive target for each 1% of attainment between 75% and 100%; and once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation. For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.

Role & responsibilities 1) Compilation , review of dossier for US , EU , AU, Canada & IL market (ORALS/NON ORALS) 2) Review of query response prepared and compiled by regulatory associates 3) Review of all the documents received from stake holder for dossier compilation , Query response and Life cycle management

Role & responsibilities Candidates having experience working for Russia, CIS, APAC, SSA (Sun Saharan African) and Brazil /LATAM market

Looking for a fresher in Regulatory Affairs to assist in document preparation, product registration, and compliance with national and international regulations. Strong communication skills, attention to detail, and a science background are preferred.

Purpose of the Job: To ensure Clariant's products comply with relevant chemical regulations, material requirements, and trade regulations across assigned regions. Verify proper HS (Harmonized System or Tariff classification) code for import/export compliance. Responsibility: • Drive strategic initiatives within chemical regulatory framework. • Investigate and analyze chemical structures to ensure regulatory compliance • Determine appropriate HS codes for chemical products based on structural analysis• Follow Regulation: CWC (Chemical Weapons Convention), INCB (International Narcotics Control Board), Central Insecticide Board or SCOMET(Special Chemicals, Organisms, Materials, Equipment and Technologies). • Collaborate across teams to assess regulatory compliance. • Collect and evaluate data per legal, regulatory, and business requirements. • Ensure material and product compliance through document and data analysis. • Maintain compliance with global and local import/export laws. • Document compliance data in systems like SAP Environment, Health, and Safety. • Communicate compliance restrictions and requirements to stakeholders. • Support implementation of regulatory changes. Requirement: • Master in Science or equivalent studies • 5+ years of experience in Chemical, Pharma or other highly regulated industries • Experience in chemical regulations, material compliance and trade regulations.• Experience with CWC (Chemical Weapons Convention), INCB (International Narcotics Control Board), Central Insecticide Board or SCOMET(Special Chemicals, Organisms, Materials, Equipment and Technologies). • Experience with SAP modules. • Accurate chemical identification. • Good to have experience in HS (Harmonized System) classification. • Analytical bent of mind, problem-solving ability, deep diving approach. • Self-motivation to learn regulations and strive for regulatory excellence. • Excellent communication and stakeholder management skills. Company Culture: • Be part of an amazing team, who will be there to support you. • A forward-looking company, with a culture of innovation and a strong portfolio in sustainable technologies. • Ongoing Professional Development Opportunities • Inclusive Work Environment • Approachable Leadership • Long term growth opportunity • Work-Life Balance • Speak Up Culture • Women's Inclusion Network of Clariant (WIN) Benefits: • Hybrid Work Model- 3 days in office and 2 days remote • Child Day Care facility fully sponsored by Clariant • In-house Cafeteria & Subsidized meals • 30 Days Annual Paid Leaves • Clariant-Sponsored Annual Health Check-Up • Centralized Company Transport for Designated Routes (Regular shift) • Employee Wellbeing & Assistance Program • Group Medical Insurance, Group Personal Accident Insurance and Life Insurance • Maternity & Parental leave policies • Performance-Based Competitive Annual Bonus Plan • On-Site Medical Assistance for Employees: Doctor Visits Available Three Days a Week with a Medical Attendant Present Five Days a Week in the Medical Room.

Role & responsibilities Review and authorize change controls, assessing their impact on regulatory submissions. * Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items. * Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines. * Assess change controls from formulation plants and categorize them based on risk to product quality and compliance. * Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS). * Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. * Evaluate and interpret post-approval changes including: * Alternate excipients * Alternate packing materials * Alternate API source additions * Site and pack additions * Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages. * Assist in developing standards and SOPs for operations and production procedures. * Stay updated with evolving global and regional regulations affecting submissions. * Provide daily activity updates to the Regulatory Affairs Manager. * Prepare monthly reports and provide timely updates to superiors. * Uphold the highest standards of professional integrity in all RA activities. * Actively participate in continuous improvement initiatives within the department. Preferred candidate profile * Master's degree in Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs. * Strong knowledge of US FDA regulatory guidelines and CMC documentation. * Excellent communication, coordination, and documentation skills. * Attention to detail and ability to manage multiple priorities effectively.

Skillventory is mandated to hire AVP, Regulatory Compliance with a leading Health Insurance company for Gurgaon. Were looking for an AVP Regulatory Compliance to drive a culture of compliance, ensure regulatory adherence, and support governance across business functions. Location: Gurgaon Experience: Minimum 8+ years in regulatory compliance, preferably in insurance and Team Handling Must Qualification: Graduate/Postgraduate with relevant certifications (Law/CS/MBA preferred) Key Responsibilities: Ensure implementation of new laws & regulations across functions Review insurance products, marketing materials, and customer communications for regulatory compliance Audit internal processes (sales, claims, underwriting, operations, etc.) for compliance gaps Drive IRDAI reporting processes & timely submissions Develop compliance frameworks, internal controls, and documentation Guide business teams on regulatory and ethical standards Conduct compliance workshops and training Support the Head of Compliance on regulatory programs and governance initiatives To review training material, modules and manuals from compliance perspective. Contact Person: Name: Ravi Kumar Sharma Contact No.: 7489933146 (Whatsapp) Email: ravikumar.sharma@skillventory.com #Hiring #ComplianceJobs #IRDAI #HealthInsurance #RegulatoryCompliance #GurgaonJobs #AVPRole #InsuranceCareers

Role & responsibilities Review of post approval changes and evaluating its impact on the products. Preparation of appropriate post approval submissions such as PAS, CBE 30 & 0, and annual reports. Management of product life cycle. Managing Team Dosage Form : Solid Oral / Nasal / Liquid/ Ophthalmics Preferred candidate profile 10+ Years of USFDA post approval submission experience USFDA Experience Exposure to ANDA /NDA post approval submissions Please share updated CV on hr19@hectorandstreak.com

**Job Description:** As a CSV Lead in the Drug Safety domain, you will be responsible for overseeing the validation process of safety systems, including but not limited, or other drug safety databases. You will lead cross-functional teams and manage CSV lifecycle activities, including planning, executing, and documenting validation efforts for drug safety systems. **Key Responsibilities:** - Lead validation efforts for drug safety systems such other similar platforms, ensuring compliance with industry standards (21 CFR Part 11, GxP, and other relevant regulations). - Develop, review, and approve validation documentation, including Validation Plans, Protocols, Reports, and Traceability Matrices. - Perform risk assessments and impact analysis of software changes or upgrades to ensure compliance with validation requirements. - Collaborate with cross-functional teams (IT, Quality Assurance, Pharmacovigilance, and Compliance) to ensure effective implementation and maintenance of validated systems. - Provide guidance and training on validation processes and regulatory requirements. - Support audits and inspections related to CSV activities and respond to findings or inquiries from regulatory bodies. - Manage the CSV lifecycle, including requirements gathering, testing, and system releases for safety systems. - Ensure that all system-related issues are identified, tracked, and resolved in a timely manner. **Qualifications:** - Bachelor's degree in Computer Science, Life Sciences, or a related field (or equivalent experience). - Minimum of 2years of experience in Computer System Validation, with a focus on drug safety systems (Argus, ArisG, or similar). - In-depth knowledge of pharmaceutical and regulatory requirements, including 21 CFR Part 11, GxP, and ICH guidelines. - Strong experience in system validation and lifecycle management of computer systems, including testing, documentation, and quality assurance processes. - Familiarity with the pharmacovigilance domain and the processes for adverse event reporting and management. - Excellent communication and leadership skills with the ability to work in cross-functional teams. - Experience with audit readiness and regulatory inspections (FDA, EMA, etc.) is a plus. - Certification in Computer System Validation or related fields is a plus.

* B.Pharm/M.Pharm with 4-6 years in Regulatory Affairs, experience in dossier preparation, and country-specific formats. * Prepare dossiers, handle queries, manage re-registration and renewal applications.

Roles and Responsibilities Prepare dossiers for regulatory submissions, including CTD/eCTD format. Ensure compliance with USFDA regulations through dossier compilation and submission. Manage RA activities from pre-clinical to post-marketing stages, covering both domestic and international markets. Develop expertise in drug regulatory affairs, focusing on row market requirements. Collaborate with cross-functional teams to ensure timely completion of projects.

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a wide range of products and services to customers across different geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Specialty Pharmaceuticals segment includes Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. Generics & APIs segment comprises Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. JGL operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing, respectively. The Mysore manufacturing site, spread over 69 acres, is USFDA approved and produces APIs targeting Lifestyle driven Therapeutic Areas. The Roorkee facility is state-of-the-art and approved by multiple regulatory bodies. Both manufacturing units are supported by around 500 research and development professionals working on new product development in API, Solid Dosage Formulations, Sterile Injectable, and other formulations. R&D facilities include an 80-bed unit for BA/BE studies. JGL's Regulatory Affairs & IPR professionals manage patents and product filings for regulatory and non-regulatory markets, ensuring a unique product portfolio. Jubilant Pharma's revenue has been growing consistently, reaching INR 53,240 Million during the Financial Year 2018-19 compared to INR 39,950 Million in the previous year. For more information about the organization, visit www.jubilantpharma.com.,

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Our people make all the difference in our success. Join us in our mission to advance the world of health. Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements. Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines. Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements. Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release. Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation. Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments. Review and approve labeling and promotional material for compliance to FDA and EU regulations. Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries. Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams. Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics. Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. Work independently and carries out the above tasks with minimal supervision. Education and Experience: B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations. Experience in supporting product development projects for product and process changes. Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. Proficient in using Microsoft Word, Excel, PowerPoint, and Project. Strong communication (written, oral) and project management skills. Able to handle multiple competing tasks with great attention to detail. Able to work independently to achieve objectives on or before schedule. Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. Comprehensive knowledge of medical device regulations and standards. Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation.,

The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,

As a Quality Control (QC) Analyst at Jubilant Generics, you will be responsible for various tasks related to ensuring the quality and compliance of pharmaceutical products. Your role will involve sampling and analyzing packing materials and raw materials, conducting in-process quality control, and preparing specifications and test procedures. Additionally, you will be responsible for maintaining artwork and shade cards, as well as calibrating and validating instruments and equipment. Your attention to detail will be crucial in recording analytical data accurately and preparing records of analysis for both raw materials and finished products, including stability samples. In this role, it is essential to uphold cGMP (current Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance at all times. You will also be involved in investigating deviations, incidents, and out-of-specification results, ensuring that corrective actions are implemented promptly. Furthermore, maintaining a clean and organized work environment is important, and you will play a key role in ensuring good housekeeping practices in the laboratory. Your contribution to these quality control processes will ultimately support Jubilant Pharma's commitment to delivering high-quality pharmaceutical products to customers worldwide. For more information about Jubilant Pharma and its operations, please visit www.jubilantpharma.com.,

The Clinical Research Scientist position at NIRAMAI Health Analytix requires a Strong Leader, Clinical Specialist, and Medical Expert with an entrepreneurial mindset to lead the clinical research and marketing division. Your role will be crucial in furthering NIRAMAI's mission of becoming a world-class AI Healthcare organization known for its Innovation, Compliance, and Compassion. Your primary responsibilities will include developing and implementing strategies for the clinical function at NIRAMAI, coordinating international and national clinical trials, and establishing a global network of Key-Opinion-Leaders to promote the adoption of innovative diagnostic solutions. You will also be tasked with ensuring compliance with healthcare regulations and standards, collaborating with various departments to design regulatory and marketing strategies, and organizing educational events to support brand marketing and business development. To excel in this role, you should possess a university degree in a relevant scientific discipline and have 7 to 15 years of experience in the pharmaceutical or medical devices industry. We are looking for a leader who can think creatively, build strong networks, and engage effectively with stakeholders and regulatory authorities. NIRAMAI Health Analytix Pvt Ltd is a health technology startup known for its Novel Cancer Detection Solution and commitment to enabling mass screening in both urban and rural areas. As a Series A funded company with a strong investor base, NIRAMAI has received numerous national and international awards, including being listed on CBInsights AI 100 2019 list. If you are passionate about making a difference in healthcare and have the expertise to lead a dynamic team focused on clinical research and regulatory compliance, we invite you to apply for the Clinical Research Scientist position at NIRAMAI Health Analytix.,

As the Director of Regulatory Research & Intelligence at Kamet Consulting Group, you will be responsible for leading and developing a team of research consultants in the life sciences and healthcare technology industry. Your role will involve overseeing regulatory intelligence, compliance support, and advisory services for clients in the pharmaceutical and medical device sectors. You will be the key authority for regulatory research activities in India, ensuring delivery excellence, quality control, and strategic insights. Your core responsibilities will include building and mentoring a team of research consultants, setting performance targets, and fostering their professional development. You will also be responsible for ensuring that all research, analysis, and regulatory intelligence meets global quality and compliance standards. Additionally, you will define and evolve the research agenda in alignment with regulatory trends and client priorities, oversee project delivery, and communicate complex regulatory insights to executive audiences. To qualify for this role, you should have an advanced degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field, with a preference for a PhD or MBA. You should have at least 10 years of experience in regulatory affairs, regulatory intelligence, or compliance within the pharma/medical devices industry, including 5 years in consulting and team management roles. Strong leadership skills, expert knowledge of global and Indian regulatory frameworks, exceptional communication abilities, project management experience, and an entrepreneurial mindset are essential for this position. Desired traits for the role include being well-read on regulatory and scientific literature, culturally adept in global teams, and having high ethical standards and a passion for quality in research and client service. Kamet Consulting Group offers a collaborative and innovative work environment, competitive compensation and benefits package, flexible working arrangements, and growth opportunities for all qualified applicants. Join us to contribute to meaningful technology in the life sciences domain and be part of a team committed to innovation.,