MSc Life Science Jobs at Biocon | Regulatory Affairs Role | Apply Now
Are you looking for MSc Life Science jobs in the pharmaceutical industry? Explore exciting Biocon Careers with this opportunity for a Regulatory Affairs Specialist. If you are passionate about Regulatory Affairs Jobs and want to work on biosimilar product registrations across global markets, this role offers excellent career growth, international exposure, and the chance to work with leading regulatory authorities.
About the Company
Biocon is a leading global biopharmaceutical company focused on developing affordable biosimilars, generic formulations, and novel biologics. Known for innovation-driven growth, Biocon offers excellent opportunities for professionals aiming for jobs in Life Science with an MSc qualification. The company plays a significant role in advancing healthcare accessibility across emerging and developed markets.
Job Description
1. Regulatory Strategy & Planning
- Develop and implement regulatory strategies for biosimilar registrations across MENA, CIS, and Non-EEA regions—particularly relevant for candidates seeking jobs in MSc Life Science.
- Align with global strategy and assess regulatory risks with mitigation plans.
2. Dossier Preparation & Submission
- Oversee preparation and submission of CTD/eCTD dossiers for approvals, renewals, and variations. This is a key task for Regulatory Affairs roles linked to MSc Life Science jobs.
- Coordinate with cross-functional teams and ensure timely submissions.
3. Agency Engagement & Coordination
- Act as the key contact for Health Authorities—experience valued in Life Science jobs.
- Lead regulatory discussions and collaborate with regional partners for submissions.
4. Lifecycle Management
- Handle post-approval changes, renewals, and labeling updates. Professionals in Life Science jobs can showcase their skills here.
- Maintain regulatory documentation and ensure timely implementation.
5. Compliance & Intelligence
- Monitor regional regulations and ensure compliance. Candidates interested in Life Science jobs will find this experience valuable.
- Provide updates and support regulatory inspections.
6. Cross-functional Collaboration
- Work with internal teams (QA, QC, Clinical, Commercial, BD, etc.)—collaboration is essential in many MSc Life Science jobs.
- Support business development and partnership activities.
Qualifications & Experience:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field; Regulatory certification is a plus. For those targeting jobs in Life Science with an MSc background, this qualification is ideal.
- Experience in regulatory affairs in the pharmaceutical/biotech industry, with experience in biosimilars, is preferred.
- Strong understanding of regulatory pathways for biosimilars (clinical and analytical similarity requirements) and ICH guidelines.
- Experience with regulatory submissions in MENA and CIS countries is mandatory.
- Familiarity with SFDA, EMA reliance procedures, and dossier localization requirements.
Required Skills & Competencies:
- Strong project management and organizational skills are essential for a regulatory affairs job.
- Excellent written and verbal communication skills.
- Strategic thinking with attention to detail.
- Proactive, collaborative, and culturally aware.
- Ability to manage multiple priorities in a fast-paced environment.
Explore top MSc Life Science jobs through Biocon Careers and build a rewarding future in Regulatory Affairs Jobs. Apply now to gain global exposure and advance your career in the pharmaceutical industry.
