Specialist Regulatory Affairs - NBE

Specialist – Regulatory Affairs Novel Biological Entity is responsible for driving global regulatory strategy, submission planning, and lifecycle management for novel biological products across key emerging markets. The role involves close collaboration with cross-functional teams to ensure timely approvals, compliance with regulatory requirements, and successful market entry.

Key Responsibilities:

• Lead end-to-end regulatory activities for innovative biological product portfolios across global markets (Emerging Markets).
• Develop and execute regulatory strategies aligned with business objectives and market requirements.
• Oversee preparation, review, and submission of dossiers (CTD/eCTD) including IND/IMPD/CTA, MAA, variations, amendments, and renewals.
• Act as the primary point of contact with country affiliates and global health authorities for regulatory interactions, queries, and inspections.
• Provide strategic guidance on regulatory pathways for biological products including clinical requirements of country of origin or single region clinical study data.
• Ensure compliance with evolving regulatory frameworks, guidelines, and quality standards.
• Collaborate with partners and cross-functional teams (R&D, Quality, Clinical, Medical, Manufacturing, commercial, marketing and supply Chain) to drive regulatory milestones.
• Identify risks in submission timelines and proactively implement mitigation plans.

Key Requirements:

• Advanced degree in Pharmacy, Biotechnology, or related field.
• Strong experience in Regulatory Affairs with exposure to biosimilars or biologicals.
• Proven experience in handling global submissions (ANVISA, SAHPRA, DIGIMED, TGA, MEDSAFE, COFEPRESS,USFDA, EMA, or other major agencies).
• Strong understanding of biosimilar regulatory frameworks and lifecycle management.
• Excellent communication, strategic thinking, and stakeholder management skills.

Key Competencies:

• Regulatory Strategy & Compliance
• Global Stakeholder Management
• Analytical & Problem-Solving Skills
• Strong Execution & Ownership