Regulatory Affairs

2 days ago


Mumbai, India Acme Services Full time

Job Description - preparation and submission of registration dossier, renewal application and variation application for ANDA / ROW submission - Preparation of respective CTD sections and submission of final query response to agency - Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval - To upload documents in national portal for respective European regulatory agency - Co-ordination with different department for getting required data for compilation of registration dossier, renewal application and variation - Review of the mockups for all regulatory submissions and commercial supplies - Maintenance of internal database - Co-ordination with consultant for national submissions, product information translation, readability testing etc - Review and approval of change control and deviations - Coordination with customer and consultant in order to timely submissions of new applications, query responses, variations and renewals - Review of variation packages


  • Regulatory Affairs

    2 days ago


    Mumbai, Pithampur, India Gepach International Full time US$ 80,000 - US$ 1,20,000 per year

    Responsibilities of a Regulatory Affairs - Manager for HOD / Senior RA Executives :Manages all the functions of the Regulatory Affairs Department including but not limited to * Scheduling activities of the department.1. Dossier Preparation and ReviewOversee the preparation of technical product dossiers, ensuring accuracy, completeness, and compliance with...

  • Regulatory Affairs

    5 days ago


    Mumbai, Maharashtra, India Win in Life Academy Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).Experience- 1-5 YearsJOB DESCRIPTION – Regulatory Affairs (Domestic)The role will involve expertise in D & C Act and Rules as well as FSSAI regulations withexperience in FDA related activities. This...


  • Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...


  • Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-54 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. - They market wide range of poultry and cattle products....


  • Mumbai, India AMPLE LEAP COGNITION & TECHNOLOGIES PVT LTD Full time

    **Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific support Responsibilities and...


  • 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...


  • Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full time

    Designation : Regulatory Affairs Specialist - Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - Experience : Minimum 2-5 years of experience in regulatory affairs - Salary : Good Hike on Current CTC - Location : Sandhurst Road Mumbai - Head


  • Mumbai, Maharashtra, India Kremoint Pharma Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Job Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...


  • Mumbai, Maharashtra, India Fusion Market Research Full time

    Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...

  • Regulatory Affairs

    5 days ago


    Andheri, Mumbai, Maharashtra, India The Hiring Experts Full time

    **Job Title: Regulatory Affairs for a reputed pharmaceutical company** 1. Review all technical documents for submission of ANDA submission and post-approval submissions. 2. Ensuring all compiled ANDAs comply with current FDA guidelines and expectations to minimize deficiencies. 3. Preparation and review of pre-ANDA meeting packages, and controlled...