Regulatory Affairs Manager

Biocon Biologics; Bengaluru; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Biocon Biologics in Bengaluru is seeking a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registrations across Emerging Markets. You will prepare and manage regulatory submissions and coordinate with affiliates and health authorities to ensure timely approvals and lifecycle compliance.

The role requires strong knowledge of CTD/eCTD formats, regional guidelines (GCC, LATAM, Africa), and experience with regional electronic submission platforms.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.
• Knowledge of CTD structure, Module 1 customization, and regional submission formats.
• Strong project management, communication, and stakeholder coordination skills.

Responsibilities

• Prepare, review, and submit regulatory dossiers for Biosimilars in Emerging Markets.
• Maintain knowledge of regional regulatory landscapes, including GCC, LATAM, and Africa.
• Support product registrations, renewals & variations.
• Ensure submission planning and regulatory timelines for launches and lifecycle management.
• Respond to health authority queries in coordination with CMC, clinical, and quality teams.
• Maintain regulatory dashboard, submission tracker, and country-specific requirements.

Skills

Regulatory affairs

Biosimilars

CTD/eCTD knowledge

Project management

Education

Bachelor's or Master's in Life Sciences/Pharmacy/Biotechnology

Job description

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, LATAM) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance.

Key Responsibilities:

• Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for Biosimilars in Emerging Markets.
• Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, LATAM, and Africa.
• Support product registrations, renewals & variations.
• Ensure proper submission planning and regulatory timelines to support product launches and lifecycle management.
• Respond to health authority queries in coordination with CMC, clinical, and quality teams.
• Maintain a regulatory dashboard, submission tracker, and repository of country-specific requirements and timelines.
• Understand local regulatory pathways for biosimilars/biologics: reliance, abridged reviews, priority review, etc.
• Familiarity with GCC-CTD and regional WHO biosimilar guidelines.
• Experience working with local affiliates or partner companies in Emerging Markets.
• Prior exposure to biosimilar guidelines in WHO, GCC, SAHPRA, INVIMA, ANVISA, etc.
• Experience with regional electronic submission platforms.

Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
• Proven track record in filing and obtaining approvals for biologics/biosimilars in Emerging Markets.
• Knowledge of CTD structure, Module 1 customization, and regional submission formats.
• Strong project management, communication, and stakeholder coordination skills.