Overview
Specialist in Regulatory Affairs for Novel Biological Entities, responsible for global regulatory strategy, submission planning, and lifecycle management for novel biological products in emerging markets.
What you'll do
- Lead end-to-end regulatory activities for biological product portfolios across global emerging markets.
- Develop and execute regulatory strategies aligned to business objectives and market requirements.
- Oversee preparation, review, and submission of dossiers (CTD/eCTD), including IND/IMPD/CTA, MAA, variations, amendments, and renewals.
- Serve as primary point of contact for country affiliates and global health authorities for regulatory interactions, queries, and inspections.
- Provide guidance on regulatory pathways, including clinical requirements and single-region clinical study data.
- Ensure compliance with evolving regulatory frameworks, guidelines, and quality standards.
What you'll need
- Post graduate education in Pharmacy/Science (advanced degree focus: Pharmacy, Biotechnology, or related field).
- 8+ years in pharmaceutical industry.
- 5 years of experience in global regulatory affairs.
- Strong experience in Regulatory Affairs with exposure to biosimilars or biologicals.
- Experience handling global submissions for agencies such as USFDA, EMA, ANVISA, SAHPRA, TGA, MEDSAFE, DIGIMED, COFEPRESS.
- Strong understanding of biosimilar regulatory frameworks and lifecycle management.
- Excellent communication, strategic thinking, and stakeholder management skills.
Details
- Location: Hyderabad, TS, India.
Read the full description and apply on the company’s own careers page.
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