Executive - Regulatory Affairs - Mumbai

2 days ago

Mumbai Maharashtra, India Domnic Lewis Pvt. Ltd Full time

**Executive - Regulatory Affairs
- Mumbai**:
**Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs
- Mumbai**

**Position Title**: Executive - Regulatory Affairs
**Grade**: C
**Reports to**: Lead/Manager - Regulatory Affairs

**Position Purpose**:

- Monitor and report the status of all product licenses in a timely and accurate manner
- Support the implementation of submission plans for new product registrations and ongoing product maintenance (e.g., amendments, renewals, updates)
- Manage SUGAM portal submissions as assigned
- Prepare and coordinate responses to queries from health authorities
- Maintain regulatory trackers, documentation, and archival systems
- Provide regulatory documentation support for tender processes

**Key Internal Stakeholders**:

- Marketing, Sales, Logistics
- Medical Affairs, Legal Affairs, Intellectual Property
- Clinical Operations, Product Teams, Brand Teams
- International Regulatory Affairs, QA, Manufacturing Sites, Regional Offices

**Key External Stakeholders**:

- Local Health Authorities
- Relevant Government Agencies

**Minimum Requirements**:

- **Qualification**: M.Pharm / B.Pharm / M.Sc
- **Experience**: 2-3 years in Indian Regulatory Affairs
- **Knowledge**: Familiarity with dossier compilation and current Indian regulatory guidelines

**Key Result Areas and Outputs**:
**1. Regulatory Compliance and Ethics**:

- Ensure alignment with company values, applicable legislation, and industry codes of conduct
- Adhere to corporate governance, audit requirements, and ethical practices
- Maintain confidentiality of sensitive company and product information
- Report any potential violations of codes or conduct standards

**2. Licensing and Documentation**:

- Monitor and track the status of all product licenses
- Coordinate updates or changes in licenses, ensuring timely communication and documentation
- Maintain organized and updated records and trackers

**3. Regulatory Strategy and New Product Launches**:

- Understand product strategy, dossier content, and regulatory intelligence
- Contribute to the planning and execution of regulatory strategies for new launches
- Ensure timely submissions and approvals for rapid market entry

**4. Cross-functional Collaboration**:

- Work closely with cross-functional teams (e.g., QA, Supply Chain, Clinical Ops, Medical, Market Access)
- Coordinate with international and regional regulatory colleagues
- Take ownership of assigned projects with mínimal supervision
- Support onboarding and mentoring of junior team members or contract associates

**5. Life Cycle Management**:

- Ensure timely compliance submissions for both commercial and clinical trial products
- Support audits and manage deviations or CAPAs as required
- Assist in import registration/renewal and production transfers
- Review and support packaging/artwork updates and local licensing

**6. Clinical Trial Support**:

- Manage submissions, responses, and approvals for clinical trials, including Phase IV and PMS studies
- Ensure compliance throughout the study lifecycle, from initiation to closure
- Prepare for Subject Expert Committee (SEC) reviews and meetings

**7. Competitive Intelligence**:

- Monitor global pipelines and regulatory trends of competitor companies
- Assess potential impact on internal development plans and provide strategic input as required

  • Regulatory Affairs Executive

    1 week ago

    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. They are...

  • Regulatory Affairs Executive

    2 days ago

    Mumbai, India Amico Formulations LLP Full time

    **Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...

  • Regulatory Affairs Executive

    2 weeks ago

    Mumbai, Maharashtra, India TheTalentforte.com Full time

    If you are interested in this opportunity, please send your updated CV + Current CTC Manufacturer and 100% Exporter of Pharmaceutical Formulations **REGULATORY AFFAIRS EXECUTIVE** Job Location: Vikhroli West, Mumbai Work Timings: 2nd & 4th Sat Off, Timings: 9.30 TO 6 OR 10 TO 6.30 Salary Range: 4 to 5 Lacs PA, depending on experience B. Pharma / M....

  • Regulatory Affairs Executive/pharmaceutical

    2 days ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai, Vile Parle, Dombivli East Regulatory Affairs Executive 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 the same industry. **Job Description**: - Managing regulatory...

  • Post Vacant for Regulatory Affairs Executive for

    2 weeks ago

    Mumbai, India T A Solution Full time

    Post Vacant for Regulatory Affairs Executive for Mumbai location in Pharma company Posted on -April 3, 2021 Designation -Regulatory Affairs Executive for Pharmaceutical Products Working location - Mulund, Mumbai Gender preference - Male/ Female Qualification - B.Sc., M.Sc., B.Pharm, M.Pharma Target Industry - Pharma Industry Experience Range - 1+...

  • Regulatory Affairs Executive/ Veterinary Pharma

    5 days ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai 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...

  • Regulatory Affairs Executive/ Veterinary Pharma

    2 weeks ago

    Mumbai, India Double HR Consultancy Full time

    Mumbai, Vile Parle 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...

  • Regulatory Affairs Executive

    5 days ago

    Dongri, Mumbai, Maharashtra, India approach Full time

    Designation: Executive - Regulatory Affairs Location: Sandhurst Road, Mumbai Department: API (Active Pharmaceutical Ingredients) Products Handled: Pharmaceutical API, Veterinary API Job Responsibilities: Regulatory Documentation: Prepare, review, and submit DMFs (Drug Master Files), CEPs, and other regulatory documents for Pharmaceutical and Veterinary...

  • Regulatory Affairs

    4 weeks ago

    Mumbai, Maharashtra, India CliniLaunch Research Institute Full time

    Job DescriptionPosition: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).Location: Andheri, Mumbai.Qualification: M. Pharm. (Experienced preferred).JOB 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 profile...

  • Regulatory Affairs

    2 weeks ago

    Mumbai, India Win in Life Academy Full time

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