Specialist Regulatory Affairs - NBE

Job Description:

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.

Qualification & Experience 

• 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.
• Regulatory Strategy & Compliance
• Global Stakeholder Management
• Analytical & Problem-Solving Skills
• Strong Execution & Ownership
• Educational qualification: Post graduate in Pharmacy/Science
• Minimum work experience: 8+ years in Pharmaceutical Industry with 5 years of experience in global regulatory affairs.
• Experience in formulation development, analytical development and quality.
• Understanding of Good Manufacturing practice/Quality Systems.
• Understanding of product development, manufacturing processes, Intellectual Property and quality.
• Technical knowledge and understanding of the regulatory requirements of different dosage forms.
• Thorough understanding of regulatory guidelines for different countries, ICH guidelines, pharmacopeia's, product filing and approval requirements.