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DDReg Pharma is hiring an Asst. Manager – Regulatory Affairs (ASEAN) for its Gurgaon location. This full-time onsite role is ideal for pharmaceutical regulatory affairs professionals with 5+ years of RA experience, particularly in ASEAN, ROW markets, and CTD/eCTD submissions.
If you are looking for high-impact pharma RA jobs in India, this opportunity offers regulatory leadership, global exposure, and cross-functional collaboration.
Key Responsibilities
As the Assistant Manager – Regulatory Affairs (ASEAN), you will:
- Review eCTD/CTD dossiers, variations, change controls, and renewals for compliance with ASEAN and ROW regulatory guidelines.
- Ensure regulatory authoring excellence, including administrative documents, labelling, technical writing, and GCC-compliant formatting.
- Track regulatory submissions, respond to authority queries, and coordinate cross-functional action plans.
- Conduct critical review of documents for guideline alignment, internal consistency, and regulatory accuracy.
- Collaborate with internal teams, external partners, and clients through structured project trackers.
- Maintain high-level, up-to-date knowledge of country-specific regulations across ASEAN markets.
- Support operational excellence by enabling efficient communication, documentation accuracy, and stakeholder engagement.
Educational Qualifications
- B.Pharm / M.Pharm
- Strong hands-on experience in regulatory affairs for pharmaceuticals
- Expertise in ASEAN regulatory frameworks (mandatory)
Skills & Competencies
- Excellent understanding of ASEAN CTD, GCC templates, and global RA standards
- Strong analytical and documentation skills
- Ability to manage cross-functional teams
- High regulatory intelligence and attention to detail
- Ability to deliver within strict timelines
Benefits
- Competitive salary and performance-based growth
- Opportunity to work with global regulatory markets (ASEAN + ROW)
- Exposure to high-quality regulatory systems and expert leadership
- Onsite role ensuring faster learning, coordination, and visibility
How to Apply
Interested candidates can apply through DDReg Pharma’s career portal or connect via the official recruitment email.
Early applications are strongly recommended due to high demand in pharma regulatory affairs jobs