Regulatory Affairs Executive

1 day ago

Ahmedabad Gujarat, India MNR Solutions Private Limited Full time

**Job Summary**:
The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR and Annual reports etc to Regulatory authorities. Queries response compilation and submission to Regulatory bodies.

**Responsibilities**:
Manages all the functions of the Regulatory Department including but not limited to-*Scheduling all the activities of the department.
- Responsible for the Lifecycle management of assigned Products according to EU regulations and other country regulation where the Product is registered.
- Develop regulatory strategies and implementation plans for the preparation and submission of new product Dossiers and CMC variations.
- CTD, ACTD Dossier compilation according to country requirements and understanding of E2E product development and filing strategies.
- Maintaining database of Regulatory submissions.
- Coordination and follow up with QC, QA, F&D, ADL, Manufacturing, packing teams, finished product manufacturers, contract manufacturer for getting all necessary technical documents as per CTD requirement.
- Prepare and review SmPC, PIL, Artwork etc.
- Ensure adherence to deadlines and Regulatory compliance of submission to health authorities.
- Preparation of Application to Regulatory bodies for all necessary approvals, FDA, CDSCO and international Regulatory bodies.
- Queries response compilation and submission to Regulatory Authorities for Product registration and renewal.
- Post approval (PAS) compliance by compilation and review of documents.
- Coordinating the inspection of the organization facilities, contract facilities and developing procedure to ensure Regulatory compliance.
- Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information (concerning current, pending and future approvals and renewals).
- Assist in reviewing product and process documentation for assigned projects to ensure compliance with requirements, as well as monitor renewals to strict deadlines.
- Communicate design changes to existing products and company practices where necessary.
- Plan and develop product trials and interpret trial data.
- Stay up to date with the latest rules and regulations.
- Any other task assigned by Head of department.

**Education, Specialized skills and Knowledge**:

- Master degree in Pharmacy in any specialization.
- Knowledge of ROW, Emerging market, ZAZIBONA and EU market requirements and ICH guidelines is must. Minimum 4 years experience in EU submission is required.
- Fluent spoken and written English.
- Task oriented with learning attitude and team work skills.

**Job Types**: Full-time, Permanent

**Salary**: ₹500,000.00 - ₹800,000.00 per year

Schedule:

- Day shift

**Experience**:

- total work: 5 years (preferred)

Work Location: In person

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India DF Pharmacy Full time

    **Job Posting: Regulatory Affairs Executive** **Location**: Sola, Ahmedabad **Salary**: ₹10,000 - ₹20,000 per month **Key Responsibilities**: - Prepare, review, and submit regulatory documents (e.g., dossiers, DMFs) to regulatory authorities. - Coordinate with R&D, QA, and production teams to gather necessary documentation for product registration. -...

  • Regulatory Affairs Executive

    2 weeks ago

    Sola, Ahmedabad, Gujarat, India WEST-COAST PHARMACEUTICAL WORKS LTD Full time

    **West coast pharma is looking for Regulatory Affairs Head - Male preferred** Qualification: B.PHARM/M.PHARM Experience: 5 to 10 years only **Regulatory Affairs Head - Pharmaceuticals Job Role**: The Regulatory Affairs Head leads the regulatory strategy and compliance for pharmaceutical products. They oversee submission of dossiers to health authorities,...

  • Regulatory Affairs Executive

    1 day ago

    Bodakdev, Ahmedabad, Gujarat, India Sunchem Industrial Corporation Full time

    Regulatory affairs executive - B Pharm or M Pharm with 2 years plus experience in similar profile or work area. **Job description**: - Preparing Dossiers for registration of products in various ROW markets and query response submission - Legalization of FDCA documents for respective country registration - Arrangement of Sample for registration submission...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Angiplast Private Limited Full time

    “Job Description” **Position**:Regulatory Affairs - Executive Cum Microbiologist** **Department: Regulatory Affairs / Microbiologist** **Min Qualification: B.Pharm, M.pharm,Bio-Medical Engineer, B.Sc or M.sc with Microbiology** **Min Experience: 3 - 5 Years** **SAARY**: 30,000 To 60,000 **Industries Preferred: Medical Device / Pharma / Bio-Tech /...

  • Regulatory Affairs Executive

    1 week ago

    Vadodara, Gujarat, India Ronak Group Full time

    Looking for an Enthusiastic, Efficient & Trustworthy Senior Executive - Regulatory Affairs for a Leading MNC “**Ronak Group”** **Company: Ronak Group (MNC)** Position**:Executive / Senior Executive - Regulatory Affairs** Experience: 2 to 7 Years Location: Vadodara, India We are looking for Energetic & Goal Oriented **Executive / Senior Executive -...

  • Regulatory Affairs Executive

    2 weeks ago

    Sachin, Surat, Gujarat, India Globela Pharma Pvt. Ltd. Full time

    **Job Description: Regulatory Affairs Executive (Fresher to 3 Years Experience)** **Position**: Regulatory Affairs Executive **Department**: Regulatory Affairs **#### **Key Responsibilities**: - **Regulatory Submissions**: - Prepare and submit regulatory documents to health authorities (FDA, EMA, TGA, etc.) for new products, amendments, and...

  • Executive - Regulatory Affairs

    1 week ago

    Ahmedabad, Gujarat, India Contract Pharmacal Corp. Full time

    Responsibilities include, but are not limited to: - Review/approve Master Carton Labels, Pallet Labels, Blister Master Proofs and Printer proofs. - Support and Prepare draft Ingredient Lists. - Support Label Claim Substantiation activities. - Support drug product listing and maintenance, as needed. - Support second sourcing projects, as needed. - Prepare,...

  • Regulatory Affairs Executive

    2 weeks ago

    Ahmedabad, Gujarat, India Winston HR Services,Ahmedabad Full time

    POSITION :REGULATORY AFFAIRS EXPERIENCE : 0 TO 1 QUALIFICATION : B.PHARM, M.PHARM. JOB LOCATION : AHMEDABAD mo: 7383005000 SHIVANI WINSTON HR SERVICES **Salary**: ₹15,000.00 - ₹20,000.00 per month Schedule: - Day shift **Experience**: - total work: 1 year (preferred) Ability to Commute: - Ahmedabad, Gujarat (required) Ability to...

  • Regulatory Affairs Assistant

    2 weeks ago

    Jarod, Vadodara, Gujarat, India Briyosis Soft Caps Pvt Ltd Full time

    **Company Description** Briyosis Soft Caps Pvt. Ltd. is a privately-owned contract manufacturer of custom dietary supplement formulations. Based in Vadodara, India, we are an FDA registered and WHO-GMP certified company. With our high-efficiency encapsulation lines operating 24/7, we have the capability to produce over 3 billion soft-gels annually. Our...

  • Regulatory Affairs Specialist

    2 weeks ago

    Ahmedabad, India Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience : Minimum 2 yearsJob Summary:We are seeking a...