Regulatory Affairs Executive

5 days ago


Ahmedabad Gujarat, India Pharmaceutical Distributor Full time

**About us**:
(BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault RIM

**Job Responsibility**:

- Prepare, compile, and review eCTD dossiers for submissions (e.g., ANDA/NDA /MAA/ANDS).
- Coordinate with cross-functional teams (QA, QC, R&D, Manufacturing, Packaging) for accurate documentation.
- Compile and validate submissions using tools such as Extedo, Lorenz docuBridge, or equivalent.
- Ensure completeness and technical accuracy of eCTD sequences.
- Troubleshoot validation issues before final submission.
- Prepare and manage post-approval changes (CMC variations, labeling updates, packaging changes).
- Submit supplements, amendments, and variations in accordance with regulatory guidelines (FDA’s PAS, EMA's Type IA/IB/II).
- Collaborate with internal departments to gather data and draft scientifically sound responses.
- Stay updated with changes in FDA, EMA, and ICH guidelines.
- Maintain regulatory databases, submission trackers, and approval records.
- Participate in audits and support regulatory inspections.

**Required Qualification & Skills**:

- Bachelor's / Master’s degree in Pharmacy or related field.
- 3-7 years of relevant experience in Regulatory Affairs for regulated markets (Health Canada/US/EU)
- In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks.
- Strong understanding of dossier structure, eCTD publishing, and submission timelines.

Experience: 3 to 7 years

Location: Ahmedabad, Gujarat (On-site)

Pay: From ₹35,000.00 per month

Work Location: In person



  • 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. -...


  • Ahmedabad, Gujarat, India nutralike formulation Pvt Ltd Full time

    **Job Summary**: The Regulatory Affairs Executive will be responsible for preparing, reviewing, and submitting regulatory dossiers for nutraceutical products intended for Rest of the World (RoW) markets. The role ensures compliance with country-specific requirements and involves coordination with internal teams, distributors, and regulatory agents for timely...


  • Ahmedabad, Gujarat, India Samarthhrconsultant Full time

    Regulatory Affairs Executive (Only Girls ) Exp: Fresher - Qualification: M.pharm / B.pharm Dholka Ahemdavad Pay: From ₹16,000.00 per month Work Location: In person


  • Gota, Ahmedabad, Gujarat, India BKM Health Pvt Ltd Full time

    (BKM) is seeking a Regulatory Affairs Executive to join our team. In this role, you will be responsible for getting new products approval from the regulated market. In-depth knowledge of US FDA, EMA, and ICH regulatory frameworks, eCTD/ACTD dossier preparation, compilation and submission. Familiar with regulatory tools like Extedo, Lorenz, Veeva Vault...


  • Ahmedabad, Gujarat, India Swastik Placement Agency Full time

    **Position : Regulatory Affairs Officer/Executive (Female)** **Education : B Pharm (Preferably)** **Experience : 1-2 Years** **Work Profile**: 1. Preparation & Checking of Dossiers of formulation products for product registration in other countries. 2. Co-ordination with Manufacturer & our partner in country (With their regulatory person) 3. Travel may...

  • Regulatory Affairs

    1 day ago


    ahmedabad, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time

    **Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global...


  • 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 /...


  • Ahmedabad, India Prime Placement Full time

    Position: Regulatory Affairs Assistant - Cosmetic Industry Department: Regulatory Affairs Experience Required: 0-2 years Location: Santej, Ahmedabad Salary Range: 2.2 LPA - 3 LPA Roles & Responsibilities: 1. Handling Legal Documents and Regulatory Affairs: - Assist in the preparation, review, and submission of regulatory documents. - Maintain and...

  • Regulatory Affairs

    2 days ago


    Ahmedabad, Gujarat, India VITAL INTELLIGENCE TECHNOLOGY PRIVATE LIMITED Full time ₹ 30,00,000 - ₹ 60,00,000 per year

    **Vivanza Biosciences Limited** is seeking a highly motivated and detail-oriented professional to join our team as a **Regulatory Affairs Executive** in Ahmedabad, Gujarat. This role is ideal for an individual with foundational experience in the pharmaceutical industry who is keen to grow their career in regulatory compliance and submissions for global...


  • Science City, Ahmedabad, Gujarat, India Gp Crop are Pvt. Ltd. Full time

    To have a clear understanding of regulatory guidelines and data requirements for pesticide export. - Collect and coordinate information to prepare regulatory documentation for submission to regulatory agencies - To prepare a regulatory dossier on chemistry and residue, as per the company’s requirements and timelines. - To review PCP and other reports about...