manager - 2

3 days ago

Vadodara, Gujarat, India SUN PHARMA Full time

Job Title
Manager 2/1 – R&D Biotechnology

Business Unit
R&D1 Regulatory Affairs

Job Grade
G11A/G10

Location
Baroda

At Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."

Key Responsibilities

  • Develop and implement phase-appropriate analytical strategies for biosimilar development.
  • Lead comparability studies between biosimilars and reference products.
  • Oversee method development, validation, and transfer for characterization assays.
  • Provide high-level technical expertise across biosimilar programs.
  • Act as a technical lead in cross-functional teams including process development, regulatory, and quality.
  • Ensure all analytical activities meet global regulatory standards (ICH, FDA, EMA).
  • Support dossier preparation and regulatory submissions with analytical data.
  • Work closely with internal teams and external partners (CROs, CMOs).
  • Present analytical findings to senior management and regulatory bodies.
  • Stay updated on emerging analytical technologies and regulatory trends.
  • Drive innovation in analytical approaches and tools for biosimilar characterization.

Travel Estimate
NA

Job Requirements
Educational Qualificatio
Graduate : Masters/ PhD

Experience
Tenure : minimum 10 years

Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together

Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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