Manager -1 Biotechnology

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 450,000 - 750,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in India is seeking an experienced professional for R&D1 Regulatory Affairs. The role focuses on bioanalytical assay development in collaboration with CROs, and leading regulation-related activities for pre-clinical and clinical studies.

You will oversee TK/PK/ADA/NAB assays, guide CRO partners on study design, and contribute to regulatory dossier content. A strong background in GLP/GCLP environments and senior bioanalytical expertise is essential.

Qualifications

• M.Pharm/M.Sc/M.Tech required.
• 9+ years of relevant bioanalytical regulatory experience.

Responsibilities

• Work in close partnership with CROs for bioanalytical assay development.
• Responsible for TK, PK, ADA & NAB assay development and validation at CROs in GLP/GCLP environments to support pre-clinical and clinical studies.
• Lead the evaluation of innate immune responses for therapeutic peptides and proteins.
• Lead the assessment of adaptive immune responses for therapeutic peptides and proteins.
• Serve as bioanalytical representative at project team meetings, overseeing CRO activities including reagent generation, assay development and validation.
• Draft regulatory dossier content and oversee CROs on assay development, experimental design and sample analysis.
• Review MDRs, validation reports and bioanalytical ATPs.
• Manage regulatory queries.

Education

M.Pharm/M.Sc/M.Tech

Job description

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Company: Sun Pharmaceutical Industries Ltd

Job Title:

Business Unit:

R&D1 Regulatory Affairs

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Location:

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

• Work in close partnership with contract research organizations (CROs) for Bio analytical assay development.
• Responsible for TK, PK, ADA & NAB assay development, validation at external contract organizations (CROs) in a regulated (GLP, GCLP) environment to support pre-clinical and clinical studies.
• Lead the evaluation of innate immune responses associated with therapeutic peptides and proteins.
• Lead the assessment of adaptive immune responses associated with therapeutic peptides and proteins
• Serve as the bioanalytical representative at project team meetings and provide scientific and operational oversight of bioanalytical activities conducted at CROs including reagent generation, assay development and validation.
• Work independently and in collaboration with a subject matter expert (SME) representative of the clinical & non-clinical group.
• Identification & screening of CROs for Bioanalytical services.
• Provide guidance to contract organizations (CROs) on assay development, experimental design, troubleshooting and sample analysis.
• Review of method development reports (MDRs), validation reports and bio analytical test procedures (ATPs).
• Responsible for managing the regulatory queries.
• The candidate is expected to draft the technical content for regulatory dossier.

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Job Requirements

Educational Qualification

M.Pharm/M.Sc/M.Tech

Experience

• More than 9 years of relevant experience

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).