Specialist Regulatory Affairs

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd in Hyderabad seeks a senior Regulatory Affairs professional to lead end-to-end regulatory activities for biosimilar portfolios across global markets.

You will develop regulatory strategies, oversee dossiers and submissions (CTD/eCTD) including IND/IMPD/MAA, and liaise with health authorities and affiliates to ensure compliance.

Qualifications

• Regulatory affairs experience with biosimilars or biologics.
• Experience handling global submissions (ANVISA, SAHPRA, DIGIMED, TGA, etc.).
• Excellent communication and stakeholder management skills.

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.

Skills

Regulatory Affairs

Biosimilars

Global submissions

Stakeholder management

Strategic thinking

Communication

Education

Advanced degree in Pharmacy/Biotechnology or related field

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.

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.