Surgeway Biosciences Private Limited is hiring a Regulatory Affairs Senior Executive to manage dossier preparation and regulatory submissions for ROW markets (Philippines, Kenya, Ethiopia, Nigeria, Myanmar, Cambodia, Zambia). If you’re an M.Pharm professional with 2–3 years’ pharma regulatory experience and hands-on dossier compilation skills for South East Asia and East Africa, this role is built for you.
Primary keywords: Regulatory Affairs Senior Executive, dossier preparation, ROW markets, Surgeway Biosciences.
(Long-tail keywords used naturally throughout: “dossier preparation for ROW markets”, “Regulatory Affairs job Bengaluru – ROW countries”.)
Why this role matters
As a Regulatory Affairs Senior Executive at Surgeway Biosciences you will own end-to-end dossier preparation, ensure compliance with CTD/ACTD and country-specific guidelines for ROW markets, and be the point person answering regulator queries. This role accelerates product registrations across emerging markets and strengthens global market access initiatives.
Key Responsibilities
- Lead dossier preparation and compilation (CTD / ACTD / country-specific) for ROW markets such as Philippines, Nigeria, Zambia, Ethiopia, Kenya, Myanmar, Cambodia.
- Review and verify technical documents from manufacturing: specifications of APIs, excipients, finished product and packaging.
- Draft and review artwork, pack inserts, SmPC, patient information leaflets and related labeling documents.
- Prepare replies to regulatory authority queries and ensure timely submissions.
- Maintain submission standards and stay updated on ICH guidelines and biosimilars/drug product submission procedures relevant to ROW markets.
- Coordinate cross-functional input (QA, QC, Production, Packaging, Regulatory) for accurate dossier content.
Qualifications & Skills
- M.Pharm (preferred) or equivalent; 2–3 years’ experience in Regulatory Affairs with demonstrated experience in dossier preparation for ROW markets (South East Asia / East Africa preferred).
- Strong knowledge of CTD/ACTD structure and country-specific dossier requirements.
- Familiarity with biosimilars and drug submission pathways in ROW countries.
- Excellent English communication skills (written & verbal).
- Systematic problem-solving approach, strong PC and internet research skills.
- Immediate joining or within 15 days preferred.
Benefits (what Surgeway offers)
- Structured growth and in-house training programs (coaching, collaboration, performance).
- Exposure to ROW regulatory processes across multiple emerging markets — strong career visibility.
- On-site Bengaluru role with opportunities for cross-functional learning and dossier ownership.
- Competitive salary (see below).
How to Apply
- Email your resume to info.sb@surgeway.com with subject: “Regulatory Affairs Senior Executive – ROW Markets – [Your Name]”.
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