Regulatory Affairs

2 weeks ago


Andheri Mumbai Maharashtra, India Fiza Healthcare Pvt Ltd Full time

Regulatory JD
- ensure that the company's products comply with the regulations of the regions where they are distributed.
- keep up to date with national and international legislation, guidelines and customer practices.
- prepare dossiers, documents and samples as per requirement of markets for participation in tenders.
- collect, collate and evaluate scientific data from a range of sources and prepare dossiers as per the market demand in CTD /ACTD formats.
- monitor and set timelines for registrations variations and renewal approvals and submissions.
- write clear, accessible product labels and patient information leaflets.
- advise country sales managers on regulatory requirements.
- provide strategic advice to senior management throughout the development of a new product.
- manage teams of colleagues involved with the development of new products.
- undertake and manage regulatory internal audits..
- review company practices and provide advice on changes to systems.
- liaise with, and make presentations to, regulatory authorities.
- follow up with marketing team for marketing authorization, registration data and status.
- take part in the development of marketing concepts and approve packaging and advertising before a product's release.
- Experience in Dossier.
- Experience - 5 to 7 Years.

Pay: ₹30,000.00 - ₹35,000.00 per month

Schedule:

- Day shift

**Experience**:

- total work: 4 years (preferred)

Work Location: In person


  • Regulatory Affairs

    2 months 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...


  • Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full time

    Seeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...


  • Andheri, Mumbai, Maharashtra, India Eway IT Solutions Full time

    Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc.  Provide expert regulatory input to in-licensing evaluations and due diligence activities  Provide advice about regulations to manufacturers/scientists  Ensure that quality...


  • 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,...


  • Mumbai, Maharashtra, India Double HR Consultancy Full time

    Female - Urgent: Regulatory Affairs Executive(Female)/ Pharmaceutical Mumbai, Vile Parle Share VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing...


  • Mumbai, Maharashtra, India Glendale Biomed Pvt. Ltd Full time

    **Vacancy**: For Regulatory affairs officer **Job description** **Roles and Responsibilities** 2) To check artworks for regulated/ semi regulated countries. 3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & TP 4) Handling of queries pertaining to regulatory submissions from various regulatory...


  • Mumbai, Maharashtra, India Double HR Consultancy Full time

    VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...


  • Powai, Mumbai, Maharashtra, India HaystackAnalytics Full time

    **Responsibilities** - Support in creating regulatory and quality policy plan as needed internally and externally - Work with internal personnel and external agencies to implement relevant regulatory requirements - Maintain and submit regular follow up documentation to regulatory/ quality agencies and participate in audits as needed - Document review and...


  • Mumbai, Maharashtra, India Planet Science Full time

    **About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...


  • Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full time

    Job Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...


  • Goregaon, Mumbai, Maharashtra, India Zivira Labs Private Limited Full time

    _**Regulatory Affairs Associate**_ As regulatory affairs associate you'll be the crucial link between the company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed or manufactured, meet the required legislation. **Products include**: - Pharmaceuticals -...


  • 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...


  • Manjri, Pune, Maharashtra, India Fusion Market Research Full time

    _**Duties/Responsibilities**:_ - Works in the regulatory affairs department on assigned projects. - Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies. - Collaborates with key staff from Planning, Product Development,...


  • Vile Parle, Mumbai, Maharashtra, India Vision Enterprises Full time

    Required Regulatory Affairs Executive in Pharma Industry. Industry Background:Pharma (HO) Post: Regulatory Affairs Executive Gender: Preferably Female. Qualification : - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. **Position 4 : Regulatory Executive (preferably female)** **Eligibility**: - M. Sc / B. Sc / M. Pharm / B....


  • Mumbai, Maharashtra, India Double HR Consultancy Full time

    VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...


  • Sion, Mumbai, Maharashtra, India Fast growing pharma company Full time

    Please find JD for Regulatory Affairs (ROW Market formulation): 1. Preparation of Dossier in CTD, ACTD and country specific format. 2. Resolving queries received from various Ministry of Health. 3. Preparation of Technical master file for Medical Device. 4. Finalization of Artwork as per Country specific guidelines. 5. Co-ordination with vendors for DMF...


  • Sion, Mumbai, Maharashtra, India Automobile dealership Full time

    Please find JD for Regulatory Affairs: 1. Preparation of Dossier in CTD, ACTD and country specific format. 2. Resolving queries received from various Ministry of Health. 3. Preparation of Technical master file for Medical Device. 4. Finalization of Artwork as per Country specific guidelines. 5. Co-ordination with vendors for DMF and API related data. 6....


  • Mumbai, India Kenvue Full time

    **Executive, Regulatory Affairs**-2307003094W Description Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), is currently recruiting for: Executive Regulatory Affairs **Job Description General Header Statement** This position reports into Manager Regulatory Affairs and is based at Mumbai. **Who we are** At Kenvue, part of the Johnson &...


  • Mumbai, India Medico Remedies Pvt. Ltd. Full time

    Company DescriptionMedico Remedies Ltd is a rapidly growing Finished Pharmaceutical Formulations company for tablets, capsules, external preparations focused on increasing its presence in the developing markets of the world. We are looking for competent and experienced people to join in our growth journey.Role DescriptionThis is a full-time on-site role as a...


  • Mumbai, Maharashtra, India Medico Remedies Pvt. Ltd. Full time

    Company DescriptionMedico Remedies Ltd is a rapidly growing Finished Pharmaceutical Formulations company for tablets, capsules, external preparations focused on increasing its presence in the developing markets of the world. We are looking for competent and experienced people to join in our growth journey.Role DescriptionThis is a full-time on-site role as a...