Regulatory Affairs Manager

3 days ago


Pune, India Whatjobs IN C2 Full time

Dear Candidate, We are hiring for the Regulatory Affairs role-handling the below job responsibilities, Job Title: Regulatory Affairs Manager Company: Brinton Pharmaceuticals Ltd. Location: Kharadi, Pune Salary: Best in Industry Joining: Immediately Job Description: Regulatory Affairs Manager Position Overview: We are seeking an experienced and resourceful Regulatory Affairs Manager to lead efforts focused specifically on product approvals, price compliance, and regulatory risk mitigation in support of sales, pricing, and marketing. Key responsibilities include obtaining necessary approvals, ensuring price compliance, reviewing promotional materials, and addressing regulatory risks in domestic and international markets. Key Responsibilities: Product Registration & Approvals: Independently manage the full lifecycle of product dossiers and lead registration, renewals, and post-approval updates. Identify, analyse, and communicate relevant domestic and international regulations impacting product registration for all assigned markets, ensuring the team is informed of regulatory changes affecting submission strategies. Lead the preparation and coordination of regulatory submissions for each product launch, ensuring all requirements and deadlines are met for timely approvals. Oversee approval timelines, identify possible delays, and implement corrective actions to meet deadlines. Team Leadership & Cross-Functional Coordination: Manage, train, and mentor the regulatory team for performance and capability enhancement. Collaborate with cross-functional teams to ensure alignment with regulatory objectives. Engage in cross-functional collaboration to strategize the preparation and submission of product registration dossiers. Follow up with domestic/international regulatory agencies to secure early approval and marketing authorization that align with the company's global expansion and marketing plans. Audit Readiness and Documentation: Maintain regulatory documentation in audit-ready condition for internal, partner, or government audits. Maintain structured, compliant filing systems for domestic/international product dossiers and communication logs. Documentation preparation & Validations ensuring completeness and accuracy. Regulatory Intelligence & Risk Management: Monitor changes in regulatory guidelines, including gazette notifications, policy changes, and NPPA updates. Analyze potential risks and proactively implement compliance measures to mitigate disruptions to product sales or availability. Qualifications: Education: Pharma/Science background Experience: 6+ years in Regulatory Affairs Skills Required: The candidate must master the standards behind product quality, efficacy, and safety. This also means interpreting requirements for things like promotional literature, product labels, and information leaflets—and using this knowledge to help products succeed. To Apply: Interested candidates should submit their resumes via email to Please include "Application for Regulatory Affairs Manager " in the subject line.



  • Pune, India Salahkaar consultants Full time

    Job Title - Regulatory Affairs Experience - 3 -5 years in finished doses form Location - Pune Industry - Leading Pharma Industry Roles and Responsibilities To coordinate and preparation of Quality Agreements. Maintain the required documents for Regulatory Affairs. Liaising with customers and regulatory authorities regarding quality matters, including...


  • Pune, Maharashtra, India Batavia Pharma Pvt Ltd Full time

    Role & responsibilitiesRole Overview:The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory...


  • Pune, Maharashtra, India Philips Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job TitleRegulatory Affairs SpecialistJob DescriptionJob title:Regulatory Affairs SpecialistYour role:Be recognized as a key talent in International Regulatory filings and procedures.Be considered a key regulatory point person in Centralization of Regulatory Operations and enable the regulatory compliance in Markets where Philips products are...


  • Pune, Maharashtra, India Emcure Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Role: Regulatory Affairs ManagerJob Location: PuneExp: 8-14 YearsQualification: B.Pharm/M.PharmJob Responsibilities:Dossier preparation, Submission, Compilation, Query Response, Variation fillingResponsible for pre and post approval activities.Handling Europe Market.Strong knowledge of EU regulatory frameworks and guidelines (e.g., EMA, ICH, eCTD).Experience...


  • Pune, Maharashtra, India Varex Imaging Corporation Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    To apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.SummaryVarex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional...

  • Regulatory Affairs

    3 days ago


    Wagholi, Pune, Maharashtra, India SYS Research Full time

    **Responsibilities** As a regulatory affairs officer, you'll need to: - ensure that a company's products comply with the regulations of the regions where they want to distribute them - keep up to date with national and international legislation, guidelines and customer practices - collect, collate and evaluate scientific data from a range of sources -...


  • Wagholi, Pune, Maharashtra, India Statistical Pharma Full time

    **Regulatory Affairs Officer Duties & Responsibilities** The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities: - Preparing submissions of licence variations and renewals to strict deadlines; - Ensuring that a company’s products comply with regulations; - Keeping abreast of international legislation,...


  • Pune, India Umedica Laboratories Private Limited Full time

    UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...


  • Pune, Maharashtra, India Philips Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Job TitleRegulatory Affairs Operations SpecialistJob DescriptionJob title:Regulatory Affairs Operations SpecialistYour role:Assisting, supporting, coordinating and preparing regulatory submissions for product licensing to ensure accuracy and expedite approval processes and identifies, defines and addresses problems that are not immediately evident but...

  • Regulatory Affairs

    1 week ago


    Pune, Maharashtra, India Kelly Services Internal Full time

    **Job Title**: Regulatory Affairs Engineer **Locations**: Pune, India **Job Description**: - **A Bachelor’s degree or higher in a technical field, health /Medical sciences or related.**: - **Mandatory Background in the global medical devices Regulationindustry would be considered a strong plus.**: - **Good knowledge on International regulation,...