Manager - Regulatory Affairs - Pharmaceuticals - US Market

Company : The role is with One of the India's Largest Pharmaceutical Manufacturing Company.

Job Description : Manager (Labeling) Regulatory Affairs

Function : R&D (Formulations), Regulatory Affairs Department -2

Location : APLRC -I, Bachupally, Hyderabad

Job Purpose : This position is for US regulatory team responsible for filing ANDAs/NDAs/ Supplements and Amendments etc.

Key Accountabilities :

Key Accountabilities :

Process/ Operational :

- Planning, reviewing and submission for assigned ANDA and NDA projects within timelines.

- Adherence to high quality, and regulatory standards in dossiers.

- Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response.

- Monitor regularly the CDER latest labeling revision for updating our labeling in-line with RLD labeling.

- Review and authorizing regulatory change controls. Knowledge of eCTD, Module 1

- Monitoring of RLD patent and exclusivity expirations, to update US marketing generic product labeling, Regular monitoring of orange book cumulative supplements to update patent and exclusivity certification.

- Regular web search for tracking and updating USFDA regulatory guidelines, ANDA forms ANDA check list, IIG data base, Federal register, citizen petitions, updation of PIV certifications, updation of competitive Generic Therapy products, List of off patent and exclusivity.

Strategic :

1. Formulate US regulatory filing strategy for new projects.

2. Preparing quarterly and monthly targets. Allotting and evaluating targets of the team.

3. Good interpretation skill for FDA guidelines and 21 CFR.

Role Holder Profile :

- Education : B. Pharmacy/M. Pharmacy

- Experience : More than 6-10+ Years in US regulatory affairs.

- Basic Skills and Competencies: Computer knowledge/eCTD software knowledge