Manager Regulatory Affairs - Delhi
The Position
Ensure that all regulatory updates are shared with local and global teams in timely manner. Ensure that timely and complete regulatory actions are taken regarding assigned product/therapeutic area. Ensure operational RA tasks are executed in timely manner
Tasks & Responsibilities
- Strategies comply with regulations, Liaise with Health Authority and ensure earliest submission and registration in the country.
- Follow-up regulatory approvals for the products per registration plan.
- Liaise with Health Authority and Ensure earliest submission & approvals at the right time to ensure quick implementation of proposed CMC changes as per global timelines.
- Renewal on time to ensure uninterrupted availability of products in the country.
- Amendments and updates are approved on time to ensure study is continued in the country and ensure timely notification of notifiable updates.
- Follow-up on submitted applications at HA.
- Ensure all regulatory updates are shared with local and global team in timely manner.
- Follow the RI procedure of making entry and impact assessment of each relevant update in RINTOOL to maintain RIN database.
Requirements
- Education: Bachelor’s degree in pharmacy or similar medical education.
- Pharma experience with regulatory focus in a multi-national for at least 4-6 years.
- Solid understanding of D&C Act and Rules.
- Understanding of working practices at HA.
- Experience of direct interactions with Regulatory Authorities.
- Eye for details
- Analytical skills
- Communication skills
- Negotiation skills
- Position is based in Delhi
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