"Unlock Your Career in Regulatory Affairs at Piramal: Executive Regulatory Affairs Opportunity in Mumbai!"
"Unlock Your Career in Regulatory Affairs at Piramal: Executive Regulatory Affairs Opportunity in Mumbai!"

Piramal Molecular Biology Executive Job – Regulatory Affairs Vacancy, Apply Online

Executive Regulatory Affairs

Company: Piramal

Location: Mumbai, Maharashtra, India

Job Description:

The incumbent will be responsible for reviewing and finalizing regulatory documents, providing regulatory documents to institutional and ecommerce team, compiling and submitting regulatory dossier to export team, preliminary review of artworks and promotional material, understanding and staying up to date with all relevant regulations, maintaining a repository of regulatory and scientific documents, follow all departmental SOPs.

Key Stakeholder:

Internal: Marketing, Supply Chain, Quality Assurance, R&D, Sales, Business Development

External: Corporate Regulatory, Corporate Legal

Reporting Structure: Chief Manager – Medical and Regulatory Affairs

Qualifications:

  • MSc (Life Science/ Biology/ Biochem/ Molecular Biology) with 3 years of experience
    OR
  • BSc (Life-Sciences/ Biochem /Biotech)/BPharm with at least 5 years of experience

Experience:

  • 2-5 years of experience
  • Well-versed with regulations such as FSSAI, D&C Act, DMR Act, BIS, Legal Metrology
  • Has a good understanding of the operational processes of FSSAI, DCGI and other regulatory bodies
  • Previous regulatory experience in drugs and/or nutraceutical
  • Ability to critically review manufacturing, pharmacology, pre-clinical and clinical data, reports, literature, and documentation

Responsibilities:

Regulations and Compliance:

  • Execute tasks as per SOP and work process
  • Read and understand all regulatory requirements as per business needs
  • Stay updated on new regulations
  • Liaise with internal stakeholders to ensure OTIF delivery of projects

Regulatory Review:

  • Review documents for regulatory compliance
  • Conduct review of artworks of assigned products
  • Conduct review of labels, pack inserts, promotional material – banners, leaflets, print ads, TVC, social media campaigns of assigned products
  • Support marketing in evaluating NPDs of assigned projects

Exports, Institutional Sales & Ecommerce:

  • Search, read and understand regulatory requirements of export markets
  • Prepare product dossiers for registration
  • Provide all regulatory documents in a timely manner
  • Archive all submissions
  • Update and maintain the status of regulatory filings
  • Ensure regulatory compliance in export markets post-registration

Documentation:

  • Maintain a repository of regulatory and scientific documents
  • Maintain a tracker for trademarks, artworks, promotional material, exports, institutional sales
  • Archive all regulatory correspondence

Other Skills:

  • Interact and maintain relations with a cross-functional team
  • Ability to independently manage assigned tasks
  • Basic IT knowledge

Qualifications:

  • MSc (Life Science/ Biology/ Biochem/ Molecular Biology)
    OR
  • BSc (Life-Sciences/ Biochem /Biotech)/BPharm

APPLY ONLINE HERE

Keywords: Executive Regulatory Affairs, Regulatory Affairs, MSc Mol Bio, Biology, Biochem, Life Sciences, Mumbai, Maharashtra, India, Regulatory Compliance. Piramal Molecular Biology Executive Job – Regulatory Affairs Vacancy, Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like TwitterTelegramFacebook and Instagram.

Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.