Jr. Manager / Deputy Manager- Regulatory Affairs

Role & responsibilities

1. Author, review, prepare dossier for US and EU markets (ANDA/505(b)2 applications / MAA).
2. Regulatory strategy design, preparation, gap analysis of submission documents and authoring technical reports for cross functional teams.
3. Hands on experience on SPL software to prepare labels, eCTD software to publish dossiers and eCTD life cycle management.
4. Pre-submission advice on CMC, labeling and Bio studies to cross functional teams.
5. GDUFA compliance management.
6. Post approval submission management activities for approved products.
7. Advise/guide on end-to-end regulatory activities related to US market applications to Cross Functional Teams.
8. Active participation in regulatory inspection preparation and represent the regulatory function.
9. Conduct training sessions on the latest regulatory advances and requirements.
10. Systematic process development of policies and procedures for US market registrations.
11. Relationship management with cross functional teams and external regulatory service partners.

Preferred candidate profile

1. At least 3 to 8 years of experience in US and EU market Regulatory Affairs Department of any top pharma companies.

2. Registration experience in other markets like Canada and Australia will be added advantage.

3. Must have hands on experience in submission of at least 5 - 10 ANDAs/MAA independently and management of 3 - 5 products life cycle management.

4. Must be Proficient in written, verbal, Computer skills and business communication in english.

5. Deep knowledge on US FDA, EMA, ICH guidelines and capability to interpret for implementation.

6. Should be self motivated and result oriented.

7. Ability to multitask and prioritize responsibilities.

8. M. Sc. or M. Pham