(High Salary) Assistant Manager- Regulatory Affairs

3 weeks ago

Mumbai, India Domnic Lewis Private Limited Full time

Job Description We are looking for an Assistant Manager- Regulatory Affairs and Pharmacovigilance for a Global Pharmaceutical MNC based in BKC, Mumbai Position: Assistant Manager- Regulatory Affairs (Domestic market) Experience: 7+ in Regulatory affairs for domestic market Location: BKC, Mumbai Purpose of the Role: Ensure the highest professional standards in Regulatory Affairs and Pharmacovigilance to align with business objectives, values, and regulatory compliance. Key Responsibilities: - Maintain and upload data to Health Authority databases (e.g., SUGAM, FDA). - Compile and submit applications for product registration (drugs, medical devices, food supplements). - Handle CMC (Chemistry, Manufacturing, and Controls) queries and lifecycle management, including labeling, license renewals, and artwork reviews. - Develop and implement regulatory strategies for export markets and ensure compliance with CDSCO and international regulations. - Support inspections, audits, and internal Quality Management Systems (QMS). - Manage product complaints, recalls, and suspected falsified products. - Maintain global and local regulatory databases. Profile Requirements: - Qualifications: B.Pharm/M.Sc. with 78 years of experience; MBBS/M.Pharm/Ph.D. (preferred). - Skills: Strong understanding of CMC, non-clinical, and clinical data; proficiency in MS Office; excellent communication and organizational skills. - Competencies: Knowledge of regulatory requirements, drug development, risk-benefit analysis, adaptability, and teaching ability. Key Attributes: Professional discretion, ability to work independently, attention to detail, and enthusiasm for maintaining high standards in regulatory and pharmacovigilance activities.

  • High Salary: Medical Affairs Manager

    3 weeks ago

    Mumbai, India QR678 Full time

    PLEASE DO NOT APPLY IF YOU DO NOT HAVE AT LEAST 15 PUBLISHED PUBMED INDEXED RESEARCH PAPERS Senior Manager, Medical Affairs, QR678 Location: [ Bandra Kurla Complex, Mumbai ] Job Timing: 10:00 AM to 7:00 PM Salary Range: ₹9 - 18 LPA About the Company: QR678 is a leading name in the field of advanced hair restoration treatments, recognized for its innovative...

  • Associate - Regulatory Affairs

    6 days ago

    Mumbai, India Colgate-Palmolive Full time

    Relocation Assistance Offered Within Country 139208 - Mumbai, Maharashtra, India ***: **About Colgate-Palmolive**: Do you want to come to work with a smile and leave with one as well? In between those smiles, your day consists of connecting with others across the world, full of stimulating discussions, and making impactful contributions! If this is how...

  • Assistant Manager – Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Orion Pharma Full time

    About your role We have vacancy for Global Regulatory Expert role in Regulatory Affairs team We are looking for Assistant Manager This individual will be based in Mumbai Hyderabad The candidate has the possibility to utilize his her own strengths with the support of the professionals Your key responsibilities Responsible for preparation checking review of...

  • Regulatory Affairs Manager

    3 weeks ago

    Mumbai, India Chemill Pharma Ltd. Full time

    Purpose of the Role:Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams,...

  • Regulatory Affairs Manager

    2 weeks ago

    Mumbai, India Chemill Pharma Ltd. Full time

    Purpose of the Role:Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams,...

  • Regulatory Affairs Manager

    2 weeks ago

    Mumbai, India Chemill Pharma Ltd. Full time

    Purpose of the Role:Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams,...

  • Regulatory Affairs Manager

    3 weeks ago

    Mumbai, India Chemill Pharma Ltd. Full time

    Purpose of the Role: Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading...

  • Regulatory Affairs Manager

    3 weeks ago

    Mumbai, India Chemill Pharma Ltd. Full time

    Purpose of the Role: Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading...

  • Regulatory Affairs Manager

    3 weeks ago

    Mumbai, India Chemill Pharma Ltd. Full time

    Purpose of the Role: Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading...

  • Regulatory Affairs Manager

    3 weeks ago

    Mumbai, India Chemill Pharma Ltd. Full time

    Purpose of the Role: Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading...