VP – Regulatory Affairs for Diagnostics, Nutraceutical Ingredients and Foods, Biologicals and Agriculture

Job Opportunity: VP - Regulatory Affairs for Diagnostics, Nutraceutical Ingredients and Foods, Biologicals and Agriculture

Location: Avesthagen Limited, Bangalore

Position Type: Full-Time No. of Posts: 1

About Avesthagen:

Avesthagen is a global leader in genomics and precision medicine, recognized for pioneering research into rare diseases and the genomics of the Parsi community through the Avestagenome Project. We are seeking an experienced Regulatory Affairs Specialist to contribute to our research activities, ensuring compliance with regulatory standards across diagnostics, nutraceutical ingredients, biologicals and agriculture and supporting the successful operation of our biobank.

Key Responsibilities:

Regulatory Affairs and Compliance:

• Lead and oversee the regulatory affairs for research activities involving diagnostics, nutraceutical ingredients, foods, biologicals and agricultural products.
• Ensure compliance with global regulatory standards for clinical research, biobanking and genomics projects.
• Oversee the lab operations and biobank management under the Avestagenome Project, ensuring sample collection, processing, storage and data integrity comply with GLP, QA/QC and ethical standards.
• Manage and coordinate regulatory activities for key institutional committees (IREC, IBSC, IC-SCR), ensuring all research complies with ethical guidelines and biosafety standards.
• Liaise with regulatory bodies on biologics R&D, scale-up and manufacturing activities.
• Manage audits and clearances from regulatory bodies, ensuring the company adheres to all regulatory requirements.
• Support the BD team in expanding the business network and securing deals for the company.
• Drive revenue generation through business development activities across all verticals.

Research Support and Coordination:

• Assist researchers by providing regulatory guidance for research proposals, coordinating committee meetings, agendas and necessary documentation.
• Ensure that all institutional and regulatory protocols are strictly followed to maintain ethical standards and compliance throughout the research lifecycle.
• Foster team development and cultivate future leaders.

Qualifications:

Education:

• PhD or MD in biomedical sciences, genomics, clinical research, molecular biology or a related field.

Experience:

• A minimum of 5 years of experience in regulatory affairs, clinical research, biobanking, genomics or precision medicine, with a focus on biosimilars.
• In-depth knowledge and prior experience working with institutional committees (IREC, IBSC, IC-SCR) and ensuring regulatory and biosafety compliance.
• Strong understanding of regulatory requirements across genomics, biologics and new product development, with specific expertise in Indian, EMEA and USFDA regulations.
• Proven track record in managing research projects, lab operations and biobank compliance, ensuring adherence to ethical and safety standards.
• Demonstrated experience managing regulatory audits and interactions with regulatory bodies.

Skills:

• Excellent organizational, communication and project management skills.
• Strong ability to collaborate across departments and with external stakeholders to ensure regulatory compliance.

Benefits:

• Competitive salary and benefits package.
• Direct involvement in groundbreaking genomics and precision health research.
• Collaborative, innovative work environment offering opportunities for professional growth and career advancement.

How to Apply:

If you are passionate about advancing genomics and precision medicine, please submit your CV, cover letter and a summary of your clinical research and biobank management experience to [email protected] by 31 Jan 2025. Please include “Regulatory Affairs Specialist Application” in the subject line.