Regulatory Affairs Jobs for Experienced Candidates | Biocon Biologics Bangalore
- Build a Global Regulatory Career at Biocon Biologics – Apply for Regulatory Affairs Specialist in Bengaluru
- Key Responsibilities
- Regulatory Strategy & Execution
- Compliance & Documentation
- Cross-functional Collaboration
- Regulatory Intelligence
- Required Qualifications
- How to Apply
- Job Summary Table
Biocon Biologics Regulatory Affairs Specialist Job | Hiring MPharm/PhD Candidates in Bengaluru
Biocon Biologics is hiring Regulatory Affairs Specialists in Bengaluru. MPharm or PhD graduates with experience in biosimilar filings and CMC strategy are encouraged to apply.
Build a Global Regulatory Career at Biocon Biologics – Apply for Regulatory Affairs Specialist in Bengaluru
Are you passionate about biosimilars and regulatory strategy? Biocon Biologics, a global leader in biopharmaceutical innovation, is inviting applications for the role of Regulatory Affairs Specialist at their Bengaluru, Karnataka facility.
This role is ideal for highly skilled professionals with a strong understanding of CMC regulatory strategy, dossier preparation, and global filings, especially in the biosimilars domain.
Candidates with a Master’s (MPharm) or Doctorate (PhD) degree in life sciences or related fields are welcome to apply.
Key Responsibilities
Regulatory Strategy & Execution
- Develop and implement CMC regulatory strategies for biosimilar product registrations globally
- Coordinate with cross-functional teams to align regulatory deliverables with development plans
- Prepare and manage high-quality global submissions: IND/IMPD, CTA, BLA/MAA, and briefing books
Compliance & Documentation
- Ensure dossiers and DMFs are maintained as per regulatory requirements
- Oversee lifecycle management activities for approved products
- Provide expert input during regulatory authority meetings and scientific advice sessions
Cross-functional Collaboration
- Liaise with global partners to streamline regulatory efforts
- Guide internal teams on emerging regulatory expectations and changes
Regulatory Intelligence
- Monitor and interpret global regulatory guidelines and policies
- Assess implications of competitor filings and regulatory decisions
Required Qualifications
- Education: MPharm, PhD, or equivalent in Life Sciences or related disciplines
- Strong knowledge of global biosimilar regulatory frameworks
- Minimum 4–8 years of relevant experience in regulatory submissions
- Expertise in CMC, DMF, and technical documentation
- Excellent communication and stakeholder coordination skills
How to Apply
To apply for this opportunity, visit the official Biocon Biologics job page or apply directly through LinkedIn.
Job Summary Table
| Company Name | Current Vacancies in Departments |
|---|---|
| Biocon Biologics | Regulatory Affairs (Biosimilars) |
| Required Education | Experience Required |
|---|---|
| MPharm / PhD | 4–8 Years |
To apply for this job please visit www.linkedin.com.
