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Regulatory Affairs Specialist

BANGALORE (IN)HYBRIDPOSTED: 6/4/2026
PHARMAFull-time
HIRING ORGANIZATIONBIOCON BIOLOGICSBiopharmaceuticals / Healthcare
Biocon Biologics

ROLE DEFINITION & RESPONSIBILITIES

Job Description 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/e…

REQUIRED VERIFIED SKILLS

Regulatory Affairs
FDA
EMA

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Salary for this Regulatory Affairs Specialist position is competitive and aligned with industry standards for this location.

ORGANIZATION CONTEXT & CULTURE

Biocon Biologics is a global biopharmaceutical company focused on developing, manufacturing, and commercializing high-quality, affordable biosimilars and biologics. They address critical needs in chronic diseases such as diabetes, oncology, and immunology. Their mission is to expand access to life-saving medicines worldwide.

TEAM SIZE: 10,000+ employees
INDUSTRY: Biopharmaceuticals / Healthcare

EXPECTED CAREER ROADMAP

Regulatory Affairs Executive ➔ Senior RA Specialist ➔ Regulatory Affairs Manager ➔ Director.

APPLICATION ADVISORY

Ensure your resume clearly showcases experience with: Regulatory Affairs, FDA, EMA. Prepare real-world examples demonstrating these skills for the interview.
RECOMMENDED TRAINING
1/5
Biologics Regulatory Affairs Certification

Biologics Regulatory Affairs Certification

READY TO SUBMIT?

Verify your capability profile and matching credentials before submitting direct applications.