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Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Minimum Qualifications: Bachelor's degree. 6+ years of Finance, Accounting, or related work experience.*Completed advanced degrees in a relevant field may be substituted for up to two years (Masters = one year, Doctorate = two years) of work experience. Job Overview The EMEA Payroll Staff will support the Qualcomm EMEA Payroll function, its processes, and internal or external relationships with General Accounting, Human Resources, Legal, Benefits, Employee Relations, Stock Programs, IT, Tax Auditors, ADP, and other related entities. This position will be responsible for developing, implementing, and maintaining processes that will contribute to efficient payroll processing for 5,000+ employees across multiple EMEA countries. This position will report to the Payroll Manager, located in Hyderabad, and will be responsible for coaching and guiding junior team members. The ideal candidate for this position is a people manager with 12+ years of experience, including a minimum of 3+ years in people management. We are looking for an individual with demonstrated experience in multi-country accurate and timely payroll processes who can effectively communicate with a global team. Responsibilities Own the operations of EMEA payroll for countries such as the UK, Ireland, France, Sweden, Netherlands, etc. This may include directly managing the EMEA payroll teams processing of monthly payroll, including ESPP and RSU stock reporting, benefits, tax, and social insurance requirements and reporting Timely review and first approval of multiple monthly payrolls for the accuracy, completeness and compliance Ensure compliance in operational controls around critical payroll processes such as new hires, terminations, and one-time payments Collaborate closely with the global payroll team and payroll partners on payroll processing, department initiatives, and projects Analyze payroll processes and controls, identify opportunities for improvement, and ensure global process consistency where applicable Liaise with external auditors and manage payroll-related audits Perform other special projects and analyses as directed by management Keep an eye on payroll KPIs and lead from front to improve them Minimum Qualifications Bachelors degree or equivalent foundation degree Certified Payroll Professional certification- good to have 10-12 years of total EMEA country payroll experience Demonstrable experience of mentoring junior team members Experience working in a multinational organization Expert skills with ADP Global View and Workday Excellent understanding of payroll systems, data workflows, and root cause analysis Current knowledge of applicable tax, social security, and other compliance requirements across multiple EMEA countries Fluent in spoken and written English Knowledge of taxable and non-taxable earnings and expenses; payroll tax laws and complex employee benefit programs impacting payroll Proven experience in designing and implementing processes, controls, and systems Solid understanding of equity-related transactions (RSU, ESPP gain) Ability to handle multiple tasks, set priorities, and meet deadlines in a high-volume, fast-paced environment High degree of accuracy, attention to detail & strong Excel and numerical skills Strong knowledge of payroll accounting and reconciliations Outstanding written and oral communication, organizational, and leadership skills Preferred Qualifications Masters degree in accounting Proficiency in French or any other European language Hands-on payroll knowledge of France, Sweden, and UK payrolls Any payroll certification is a plus End-to-end project experience with ADP Global View implementation Exposure or experience in mergers and acquisitions Applicants Qualcomm is an equal opportunity employer. If you are an individual with a disability and need an accommodation during the application/hiring process, rest assured that Qualcomm is committed to providing an accessible process. You may e-mail or call Qualcomm's toll-free number found . Qualcomm expects its employees to abide by all applicable policies and procedures, including but not limited to security and other requirements regarding protection of Company confidential information and other confidential and/or proprietary information, to the extent those requirements are permissible under applicable law. To all Staffing and Recruiting Agencies Please do not forward resumes to our jobs alias, Qualcomm employees or any other company location. Qualcomm is not responsible for any fees related to unsolicited resumes/applications. If you would like more information about this role, please contact .

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management and Regulatory submissions. Roles & Responsibilities: Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans. Participation in information system and software update projects as well as ongoing system validations Serve as point of contact between Amgen’s functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in Veeva Vault RIM. Independently remain current on guidance (internal/external) and translate requirements into operational activities. Represent departmental expertise on regulatory projects and regional/global workstreams. Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective Contribute to the development of the strategy for communicating with global health authorities Initiate, lead and manage process development and improvement Participation in information system and software update projects as well as ongoing system validations Required Knowledge and Skills: Advanced technical and project management skills, demonstrated experience working in and leading teams Working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc. Advanced knowledge of Veeva Vault RIM and the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards Advanced knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used Advanced knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred) Preferred Knowledge and Skills: Advanced knowledge of Veeva Vault RIM, Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans. Basic Education and Experience: Master’s degree and 3-4 years of directly related experience OR Bachelor’s degree and 4-6 years of directly related experience OR Associate’s degree and 6-8 years of directly related experience OR High school diploma / GED and 8+ years of directly related experience Preferred Education and Experience: Practical experience with submission requirements for EU, JAPAC, GCC, ZA

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms 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. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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 accommodation.

Role & responsibilities Prepare, review and submit regulatory documents for new drug applications, product registrations, amendments and renewals to the US, Brazil, EU, India and State Level authorities. Regulatory Submissions : Prepare and submit regulatory documents, including INDs (Investigational New Drug Applications) and NDAs (New Drug Applications) to regulatory authorities. Compliance and Licensing: Ensure compliance with regulatory requirements of US, Brazil, EU & India. Liaise with regulatory authorities for drug licensing, including product registrations, renewals and manufacturing licenses for local and international markets. Ensure timely submission of import licenses and NOcs (No Objection Certificates) for imported pharmaceutical products. Regulatory Strategy: Provide strategic input on regulatory requirements for new product development, lifecycle management and post-market activities, including regulatory intelligence gathering and competitive landscape analysis. Cross Functional Collaboration: Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing teams to ensure alignment with regulatory strategies and compliance. Regulatory Health Authority Communication: Act as a liaison between the company and regulatory agencies to address questions or requests regarding regulatory fillings and approvals. Documentation and Reporting: Maintain accurate and up-to-date records of regulatory agencies submissions, communications with regulatory authorities and product approval status. Regulatory Training: Assist in training internal teams on regulatory requirements and best practices to ensure overall compliance across departments. Audit and Inspection Management: Coordinate with regulatory bodies in the event of audits, inspections or investigations. Preferred candidate profile Education: Bachelor's degree in Life Sciences (Pharmacy, Biology, Chemistry or related field). Advanced degrees (e.g. Master's or Ph.D.) are a plus. Experience: Minimum 05 -07 Years of experience in Regulatory Affairs, with a focus on regulatory submissions and drug licensing in the pharmaceutical industries. Knowledge: In-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) drug development processes and regulatory submission strategies.

Skill required: Contract Management - Contract management Designation: Contracting Counsel Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Legal Buyside Contracting Role Summary – To provide comprehensive legal support to Procurement and Business teams which includes drafting, reviewing, negotiation and execution of contracts, NDA's and other documents relevant to procurement support in accordance with company policies and procedures, applicable laws and customer requirements. Provide advisory support to procurement and business teams by driving the creation of templates, standardize the templates, maintain and continuously improve the standard contracts templates and procedures for complex buyside deals in accordance with changing laws and company policies. Develop specialized subject-matter expertise in support area to seamlessly address any potential risks or issues.Complexity: Requires identifying and assessing complex problems for area of responsibility. Creates solutions in situations in which analysis requires an in-depth evaluation of variable factors. Requires adherence to strategic direction set by senior management when establishing near-term goals. Interaction is with senior management of the team, internal stakeholders third party vendors, contractors subcontractors etc., involving matters that may require acceptance of an alternate approach..Authority:Some latitude in decision-making. Acts independently to determine methods and procedures on new assignments.Impact or Decision Impact:Decisions have a major day to day impact on area of responsibility.Scope:Manages large - medium sized teams and/or work efforts (if in an individual contributor role).Relationships:Supervises:?Team members providing services on a process/project or account/portfolio of accountsExternal Relationships:?Procurement, Business Executives, Contract Management, Outside counsels, Vendors, Corporate Function related stakeholders like HR, Workplace etc. What are we looking for? Bachelor's degree in LawCertifications and Membership:?Contract related global professional certification considered a plusWork Experience:?Minimum of 5 to 15 years of experience at law firm or as in-house counsel and/or in legal outsourcingKnowledge and Skill Requirements: Expert level understanding of both commercial and legal contractual risks and displays ability to provide business-oriented legal advice Fluent in English with strong oral and written skills Experience in managing end-to-end projects and teams on function specific processes and/or areas, work with internal and external teams, and understands delivery requirements Demonstrate excellent interpersonal skills, is detail-oriented, has sound judgement, is adaptable, demonstrate promptness, accuracy, and consistency with the activities supported, and drive tasks to closure, has strong time management, prioritization, organizational skills Build trust-based relationships by delivering on commitments, ability to work under pressure, with exposure to senior management Effectively manage priorities and stakeholder expectations Able to effectively influence senior management. Good understanding of Accenture offerings and function specific services performed, very good understanding of commercial agreements, legal and compliance fundamentals, corporate business practices, and contracting regulations Comfortable with technology and has experience in the use of tools & databasesBehaviours and Attributes: Open to work with and understand cross-cultures and locations throughout Accenture global organization Understand the value of diversity and recognize the strengths that different styles, innovative perspectives and experiences bring to Accenture Demonstrate inclusion and respect for all individuals regardless of gender, race, ethnicity, religion, belief, age, disability, culture, social status and/or sexuality Leader as well as team player, collaborative and persuasive; able to work well with executives and non-executives.Work Requirements:?Travel may be required Fluency in English (and other language, depending on geography supported) with very strong oral and written communication skills. Roles and Responsibilities: Generic Responsibilities Qualifications Any Graduation

Dossier Power House

Job Description: Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top management level professionals according to clients specific needs. We are BEST-FIT Recruitment Riders do exactly what our name tells. To know more about us please visit our website: www.bestfitrecruitment.co.in We would like to inform you that presently we have professional career opportunity matching to your profile with one of our esteemed client. Please see the following position summary: Client Name: USA based Pharma Company Position: Executive - Regulatory Affairs (Formulations for USA market) Department: Regulatory Affairs Location: Ahmedabad Job Profile: Responsible for supporting the Regulatory Affairs department in its efforts to remain in compliance with the regulations of all intended market territories (USA Market). Regulatory support for assigned projects through product development and lifecycle management of products for US market. Review and approve labels in line with US regulatory requirements for assigned products. Prepare, develop, and maintain internal Regulatory informational trackers. Prepare technical documents required for submission of dossier as per country specific requirements. Respond to consumer inquiries based on approved labels and product information. Coordinate the receipt of raw material regulatory documents from vendors. Preparation of module 1 sections including labelling sections. Perform drug listing of assigned products for US market. Support publishing of ANDA submissions Support manufacturing site for commercialization and life cycle management of the approved products. Other projects and duties as assigned by Senior Management. Desired Profile: B.Sc / B.Pharm / M.Sc / M.Pharm with 2 to 5 years experience in US regulatory affairs Labelling department with growing & well established pharmaceuticals. OTC products Experience is a Plus. Must have good exposure in supporting role of ANDA filling for USA market. Exposure in Solid Oral (Tablets & Capsules) for regulated markets (USA) would be preferred. Exposure to working in US Markets is Mandatory. Ability to compile, manage and interpret data. Ability to work both independently and within a team environment. Ability to manage several tasks simultaneously. Ability to co-ordinate & manage the project with external stake holder. Effective communicator with excellent relationship building & interpersonal skills. Proficiency in Microsoft Office and Adobe Acrobat. Strong communication skills, both verbal and written. Strong organizational skills. Recruiter's Contact Details: BEST-FIT Recruitment Riders G-7, Amrit Complex, Opp: Mahavir Jain Vidhyalaya & Jain Derasar, R.V. Desai Road, Near Goyagate Circle, Vadodara-390001, Gujarat, India Mobile: 09722042906, 09722052906 E-Mail: post@bfrr.in Website: www.bestfitrecruitment.co.in

Key Responsibilities: Search and review scientific information / literature Drafting, submitting applications with all necessary information to RA for related Licenses required for Product Development. Identify and propose formulation strategy for product development. Read, discuss and plan Developmental activities, bring Innovation in work and adopting Digital Initiatives while doing scientific work. Visualize the developmental needs of the product. Work along with Cross functional team towards to meet project milestones as per timelines. Use Scientific approach to mitigate challenges during development, scale up and Technology transfer of the product. Qualification M.Pharm/Phd(Pharmaceutics): Experience- 2-6 years Additional Information

JOB DESCRIPTION Job Title: Junior Manager - Regulatory Affairs Job Location: Syngene International Limited, Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND) About Syngene : Syngene ( www.syngeneintl.com ) 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 we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role: The candidate will combine his/her knowledge of scientific regulatory guidelines, CMC regulatory and filing skills to ensure successful filing, registrations, and post-approval maintenance for the intended countries. The candidate will lead eCTD filing, Regulatory DMS and QMS system activities. Role Accountabilities The candidate s contribution will help bring the much-needed therapeutics to the unmet need of the patients, thereby positively impacting mankind. The candidate will be accountable for: Pivotal CMC Regulatory support throughout the development cycle of the novel drugs space and generics space, including small molecule biologics, in marketing authorization / DMF filing and lifecycle management, predominantly for Developed countries and for certain Emerging countries, based on the market requirement. Research on regulatory requirements for new molecules / category of products based on business need in time-bound manner and provide feasibility/technical inputs to the team. Identify requirements for IND, NDA, MAA, ANDA, ANADA and other Dossiers, prepare checklists, ensuring regulatory compliance. Interact with stakeholders, collate necessary document, Review plant and RD documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc, conduct thorough regulatory assessment, identify risks, communicate to team and client, and recommend corrective measures. Plan and develop sections, compile, author, and Publish eCTD Dossiers. Ensure timely submission. Respond to regulatory agencies on a timely basis. Responsible for Regulatory project management. Provide Regulatory strategy inputs to the team and the clients. Assessing the regulatory requirements for various business requirements as and when needed. Maintain all regulatory filings, Product Marketing authorization renewals to ensure continuous validity. Maintain, and update product dossiers/DMFs as required to meet changes in internal systems, changes in regulatory guidelines. Maintain Quality Agreement Tracker, prepare Quality Agreement Checklists, and review New Quality Agreements. Train staff in regulatory policies or procedures. Develop and maintain standard operating procedures or local working practices. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted by the company. Traveling to other sites within Karnataka if necessary, though travel requirements are minimal. Leadership Capabilities Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience Demonstrated Capability Education Experience Must have experience of 6 to 13 years in CMC Regulatory Affairs for small molecule API / Formulations (preferably in injectables) for US/Europe/Developed Markets Must have hands-on experience in investigational medicinal products and marketing authorization. Experience in Biologicals /ADC / veterinary drugs is a definite plus. Skills and Capabilities High-level English Proficiency in reading, writing, and communication Hands-on Experience in eCTD. Experience in RDMS, EDMS QMS is definite plus. Thorough understanding of CMC (API Drug Product) and skill in regulatory interpretations and application Education B.Pharm / M. Pharm / Life sciences degree with minimum 5 + years of working experience with Pharmaceutical / Life science. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e.g., DMF support, ANDA filings). Coordinate with QA, RA, Production, and RD for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc.) and internal quality audits. Experience 1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry Competencies Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. Team player with problem-solving and analytical skills. 2-5 years of experience in the QC department of a USFDA / EUGMP-approved peptide/API manufacturing company

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. Lead, manage and develop leading edge regulatory strategies leading to successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required data packages and facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development activities to provide appropriate CMC as well as regulatory strategies. critical regulatory requirements to meet the quality submission and timely approvals. Responsible for all queries received from Agency or customers. Post-approval changes and Post approval compliance. communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

Accountable to develop, implement and communicate the regulatory strategies to support registration activities for all Products for all global markets such as US, EU, Canada, Gulf and ROW Market. successful regulatory filings and approvals for Generics for Global markets. implement changes required to comply with new regulatory requirements and to effectively lead and direct the creation of required facilitate knowledge for drug development. Collaborate with development and other cross functional teams during the product development critical regulatory requirements to meet the quality submission and timely approvals Responsible for all queries received from Agency or customers Post-approval changes and Post approval compliance communicate critical aspects of ongoing project activities and influence internal/external stakeholders to meet the regulatory requirements.

Roles and Responsibilities Manage ANDAs (Abbreviated New Drug Applications) for US market approval. Coordinate with DMF (Dossier Management Facility) team for dossier compilation and submission. Prepare dossiers, variations, renewals, and amendments according to FDA guidelines. Ensure timely review of documents by internal teams and external agencies. Maintain accurate records of all regulatory correspondences. Desired Candidate Profile MS/M.Sc(Science) or M.Pharma degree from a recognized institution. Strong understanding of formulation research development principles. Excellent communication skills with ability to work effectively with cross-functional teams. 0-3 years of experience in Regulatory Affairs - Formulations with expertise in drug regulatory affairs.

Job Overview To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards. Roles and Responsibilities: Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC. Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable. Perform method validation, verification, and transfer in line with ICH guidelines. Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols. Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations. Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation. Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule. Prepare samples and documents for regulatory submissions and audits (e. g. , DMF support, ANDA filings). Coordinate with QA, RA, Production, and RD for timely resolution of issues and release of batches. Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc. ) and internal quality audits. Experience 1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry Competencies Hands-on experience with instruments like HPLC, GC, UV-Vis, and others. Sound understanding of cGMP, GLP, and regulatory guidelines Strong documentation and communication skills. Ability to work in shifts and under pressure. Team player with problem-solving and analytical skills. 2-5 years of experience in the QC department of a USFDA / EUGMP-approved peptide/API manufacturing company

Job Description Product Identification Responsibilities include screening/selection of molecules across various therapeutic segments & building a robust Product Pipeline, based on IP Challenges, product complexities and identifying opportunities and Innovative/ Niche dosage forms. IQVIA Updation: GAP Analysis to be carried out to generate tailor made reports e. g. Dosage Form, Platform Technology, Therapeutic Category etc. Tracking of the developments around Upcoming Technology, evolving Trends, & Mergers & Acquisitions. Keeping a track of FDA Guidance s for Product Development, Peer ANDA approvals, Legal Updates & Drug Shortages. 505b2 concepts: Identifying and creating differentiated 505b2 Pipeline Management of Clinical Trial & Pipeline Advocacy Screening various data sources such as Press Release, SEC Filings, Corporate Presentations & Clinical Trial Databases. Collating Data around different stages of development & maintaining CT Tracker. Portfolio Management Build a Diversified Generic Portfolio with strategic focus on Exclusive First to File Opportunities, FTM/CGT/Priority Review & Limited Competition. Providing Internal Governance to various Technical teams for Product Development, Pipeline Prioritization & Product Launch. Work Experience 4-7yrs Education Masters in Pharmacy or Business Administration Competencies Collaboration Stakeholder Management Strategic Agility Developing Talent Result Orientation Innovation & Creativity Customer Centricity Process Excellence

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master’s degree OR Bachelor’s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate’s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Wte Infra Projects Pvt Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Project description The FM CCR BA Team requires a strong Business Analyst to work in Payment Domain Responsibilities Writing business requirements documents that fully and clearly cover the user requirements. Planning the required testing ensuring traceability between requirements and test cases Undertaking functional testing of the delivered functionality to ensure it meets the requirements, where required documenting issues and managing to resolution Providing expert support to the business during User Acceptance Testing Providing user training and support for system implementations including performing user verification testing where required. Pro-actively engage, manage and build strong relationships with both business and technology stakeholders. Taking ownership of technology deliveries from high level requirement through development, testing and deployment. Provide on-going support to the technology teams as required e.g. authoring / reviewing test cases, closing out open issues / questions, managing change request process, maintaining high quality UAT plans, Issue Trackers promoting visibility within the team and to wider program stakeholders. Identify risks and issues early, plan mitigating steps and communicate these to stakeholders in a timely manner Understand business requirements for front office platform design and translate into quality technology solutions. Skills Must have 7+ years of experience in Indian and International trade finance domain Work with the business users to capture, analyse and prioritize business requirements in harmony with existing Straight2Bank NextGen cash functionalities. Hands-on experience in requirements life cycle management in banking and financial domain. Should be able to manage requirements from inception to implementation across multiple systems interfaces Sound knowledge on cash management products and services offers, corporate banking channels and industry clearing systems and the different file format utilised by clients for payments. Strong product management skills including product roadmaps, requirements gatherings. Understanding of UX principles and the ability to advocate for a user centric approach to product design and development. Familiarity with metrics and KPIS related to digital channels, including customer satisfaction and adoption stats. Nice to have -- Other Languages EnglishC2 Proficient Seniority Senior

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Apollo Pipes Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products and competition status

Literature search, Execution of Development trails, observation, results compilation for the assigned products and Writing a Laboratory note for the conducted trails. Closely monitoring of all scale up and three exhibit batches. Compilation of Scale up Report and preparation of PDR. Reverse engineering of RLD product physical characterization (i.e. Microscopic examination, soluble insoluble ratio). Submission of samples to Analytical department and Compilation of data obtained. Discussion of the results with the supervisor. Preparation of stability protocol conduct stability of the products. Preparation of equipment SOPs in Product development Department. To adhere to the organizations code of conduct strictly. To ensure good hygiene and safety in the work place. Preparation and review of Risk assessment documents (E.g Elemental Impurity, Nitrosamine impurity etc) Preparation and review of ANDA submission documents Formulation (F&D) trial executions & Review of LNB Department Supporting Activity: Maintenance & related documentation including SOP preparation/review, maintenance of qualification documents for equipment in PD Lab. Weighing balance and other equipment verification/calibration. Activities other than the defined in the Job Description are to be done, as per the requirement of HOD, by following supervisors instructions and guidance

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines. Qualification M. Pharm, M.Sc PhD Additional Information Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.

Job Description 1) Candidate should have understanding and experience in development of different types of oral dosage forms like immediate release formulation/delayed release formulations/ pellet coating and controlled release formulation,hard gelatin capsule, soft gelatin capsules, solutions, suspensions, dry powders and syrups for different Regulated and semi regulated markets. 2) Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. 3) Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures. 4) Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation. 5) Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Give timely support in resolving regulatory queries. 6) Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Interact with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products. Maintain and follow safety standards as issued by the Company. Work Experience 3 to 7 years Education Graduation Post Graduation in Pharmacy or Pharmaceutical Technology Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

As a global leader in cybersecurity, CrowdStrike protects the people, processes and technologies that drive modern organizations Since 2011, our mission hasnt changed "” were here to stop breaches, and weve redefined modern security with the worlds most advanced AI-native platform Our customers span all industries, and they count on CrowdStrike to keep their businesses running, their communities safe and their lives moving forward Were also a mission-driven company We cultivate a culture that gives every CrowdStriker both the flexibility and autonomy to own their careers Were always looking to add talented CrowdStrikers to the team who have limitless passion, a relentless focus on innovation and a fanatical commitment to our customers, our community and each other Ready to join a mission that mattersThe future of cybersecurity starts with you. About The Role CrowdStrike is looking for Analyst- Global Payroll as our payroll team is expanding This position is designed for a strong team contributor, analytically strong, numbers driven, detail-oriented Payroll leader to support our International Payroll team in our SSC-Pune, India. A strong team player and willing to go extra mile to ensure our Global payrolls/Projects are delivered timely with highest accuracy This is a fast-paced, dynamic role and you will take on interesting and challenging responsibilities as our organization continues to grow in both size and complexity This role will be a key part of the successful growth of the payroll team and located in our office in Pune, India. What You'll Do Payroll Management: Gather information required to perform payroll calculation. Calculate base salary, allowances and other components of payroll in accordance with organizational policies and procedures. Input data into payroll systems to support processing and calculating activities. Process routine payroll and related administration reports. Quality Management Review performance of software or hardware products or service components. Perform audits under stipulated conditions and highlight major incidents. Inspect Key deliverables/collaterals through toll gates. Ensure 100% compliance to internal processes and standards. Operational / Process Excellence Review current processes and report anomalies at a regular interval. Document and present feedback received through different channels. Suggest changes in input or output metrices for a process. Maintain trackers for all processes and draw actionable insights from the data. Governance & Compliance Follow legislation, policies, procedures, guidelines relevant to day-to-day operations as outlined by corporate governance policies. Vendor Management Connect with vendor monthly to discuss the ongoing issues and plan payrolls. Stakeholders Management Identify key stakeholders and the organization's relationship with them. Identify stakeholder needs, positions, and interests. Coordinate basic activities/and processes with stakeholders on a day-to-day basis. Apply knowledge of the Organization's position to respond to simple and complex queries from stakeholders. What Youll Need Bachelors Degree and or equivalent degree Minimum 3-5 years of experience with EMEA/APAC with a high-growth, fast paced environment Strong understanding of payroll systems, payroll statutory, earnings and deduction codes, GL mapping. Knowledge of ESPP, STOCK, RSU is a plus. Ability to handle multiple country payrolls and be proactive in a fast-paced environment with changing priorities. Ability to effectively communicate and provide a high level of service to internal and external customers, including all levels within the company. Individuals must be organized, analytical, and detail oriented. Experience with the following systems is preferredWorkday, NetSuite, SQL/SAP based payroll system. Work Location Kharadi, Pune (Work from Office) Shift Timing2:00 PM to 11:00 PM IST Benefits Of Working At CrowdStrike Remote-friendly and flexible work culture Market leader in compensation and equity awards Comprehensive physical and mental wellness programs Competitive vacation and holidays for recharge Paid parental and adoption leaves Professional development opportunities for all employees regardless of level or role s, geographic neighbourhood groups and volunteer opportunities to build connections Vibrant office culture with world class amenities Great Place to Work Certified„¢ across the globe CrowdStrike is proud to be an equal opportunity employer We are committed to fostering a culture of belonging where everyone is valued for who they are and empowered to succeed We support veterans and individuals with disabilities through our affirmative action program. CrowdStrike is committed to providing equal employment opportunity for all employees and applicants for employment The Company does not discriminate in employment opportunities or practices on the basis of race, color, creed, ethnicity, religion, sex (including pregnancy or pregnancy-related medical conditions), sexual orientation, gender identity, marital or family status, veteran status, age, national origin, ancestry, physical disability (including HIV and AIDS), mental disability, medical condition, genetic information, membership or activity in a local human rights commission, status with regard to public assistance, or any other characteristic protected by law We base all employment decisions--including recruitment, selection, training, compensation, benefits, discipline, promotions, transfers, lay-offs, return from lay-off, terminations and social/recreational programs--on valid job requirements. If you need assistance accessing or reviewing the information on this website or need help submitting an application for employment or requesting an accommodation, please contact us at recruiting@crowdstrike.com for further assistance. Show more Show less