Manager - Medical and Regulatory Affairs

Piramal Pharma

Mumbai/Bombay

Not disclosed

Work from Office

Full Time

Min. 5 years

Job Details

Job Description

Manager - Medical & Regulatory Affairs

Business: Piramal Consumer Healthcare
Department: Regulatory Affairs
Location: Kurla
Travel: Low


Job Overview

The incumbent will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, conducting scientific training for marketing team, responsible for co-ordinationg with third party manufacturers to obtain timely licences, licence archival, responding to medical & regulatory queries, provide scientific support for consumer queries, reviewing and approving medico marketing material, monitoring AEs, ensuring quality & integrity of information being shared with stakeholders, collaborating with others in the organization to contribute to success of the business.


Key Stakeholders: Internal
Marketing, Supply Chain, Quality Assurance, R&D, Business Development, Analytical, Packaging, Consumer Insights

Key Stakeholders: External 

KOLs, Corporate Legal, Third Party Manufacturing Partners, Consultants


Reporting Structure

Reports to Chief Manager- Regulatory Affairs

Experience
•5-8 years of experience.
•Preferred previous regulatory experience in OTC drugs.
•Has a good understanding of the operational process of Pharmacovigilance and Materiovigilance.
•Ability to critically review documents for scientific and regulatory compliance and validate scientific claims for products
•Well versed with regulations such as D&C Act, DMR Act, UCPMP, ASCI codes
•Good Analytical skills
•Communication and presentation skills

Job role

Work location

Mumbai, Kurla, Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Near Phoenix Mall, Kurla (West), Mumbai, Maharashtra, India

Department

Legal & Regulatory

Role / Category

Legal Operations

Employment type

Full Time

Shift

Day Shift

Job requirements

Experience

Min. 5 years

About company

Name

Piramal Pharma

Job posted by Piramal Pharma

Apply on company website