Are you searching for Regulatory Affairs Jobs in Pune with international exposure? π
Hereβs an exciting opportunity for experienced pharmaceutical professionals to work on Francophone (French-speaking) markets and build a strong global regulatory profile.
A reputed hiring firm in Pune is looking for a Regulatory Affairs Executive β Francophone Markets with experience in CTD/ACTD dossier preparation and international submissions.
If you have 3+ years of regulatory experience and strong documentation skills, this could be your next career breakthrough π
π Job Overview
- Position: Regulatory Affairs Executive β Francophone Markets
- Location: Pune
- Qualification: B. Pharm (Mandatory)
- Experience: 3+ Years (Freshers with strong regulatory exposure may apply)
- Industry: Pharmaceuticals / Nutraceuticals
π― Key Responsibilities
π 1. CTD/ACTD Dossier Preparation
- Compilation of CTD/ACTD dossiers (Modules 1β5)
- Ensuring regulatory compliance and documentation accuracy
- Reviewing dossiers prior to submission
π€ 2. Cross-Functional Coordination
- Working closely with QA, QC, and Manufacturing teams
- Coordinating with external regulatory consultants
- Ensuring readiness of documentation within timelines
π 3. Regulatory Submissions & Tracking
- Managing submission timelines for Francophone markets
- Maintaining regulatory trackers and document archives
- Ensuring proper submission record management
β 4. Handling Regulatory Queries
- Responding to health authority queries
- Submitting clarifications within deadlines
- Ensuring continued compliance
π Why Experience in Francophone Markets Is Valuable
Working with French-speaking regulatory authorities provides:
β Global regulatory exposure
β Expertise in international dossier management
β Enhanced cross-border communication skills
β Strong long-term career growth potential
Professionals with FF market experience are highly valued in multinational pharma companies π
π Eligibility Criteria
To apply for this Regulatory Affairs Executive role:
- B. Pharm (Mandatory)
- 3+ years of Pharma/Nutraceutical regulatory experience
- Strong knowledge of CTD/ACTD documentation
- Experience in dossier compilation and submissions
- Ability to manage multiple timelines
β¨ Freshers with internships or academic exposure in regulatory documentation may also apply.
πΌ Skills Preferred
- Knowledge of global regulatory guidelines
- Experience handling Module 1β5 documentation
- Regulatory tracking tools proficiency
- Strong analytical and documentation skills
- Time management & deadline adherence
Bonus advantage if youβve worked on international submissions π
π Career Growth in Regulatory Affairs
Regulatory Affairs remains one of the most stable and high-demand domains in the pharmaceutical industry.
With experience, you can progress to roles such as:
- Senior Regulatory Affairs Executive
- Regulatory Affairs Manager
- Global Regulatory Specialist
- Dossier Management Lead
International exposure significantly boosts salary growth and career opportunities π‘
π© How to Apply?
Interested candidates can share their updated CV at:
Make sure your resume clearly highlights:
- CTD/ACTD experience
- Francophone or international market exposure
- Submission handling experience
- Regulatory query management