DGM/GM - Regulatory Affairs - Pharma Firm

We have career opportunity as DGM Regulatory Affairs with Mumbai Based Reputed CRO at Mumbai.

Please send updated cv with below details in Mail Body.

Handled Portfolio for Approved ANDA

Handled Filing for US & EU Markets.

Number of Team Members

Handled Topical Semi Solid,Semi solid for US & EU Market.

Purpose of the position :

This is a strategic Lead role ensuring adherence to changing RA scenario while developing new/optimum approaches to achieve business goals. Needs to contribute to strategy planning both within and external to organisation. Ability to work effectively in multinational/multi-culture environments is must.

Responsibilities

1. Shall have adequate exposure and hands on in handling regulatory filing and queries related to Finished dosage formulation and to some extent to API specially in Topical Semi Solid.

2. Provide strategic guidance to achieve organizational registration goals

3. Recruit, develop and mentor RA team members & facilitate team output

4. Assess emerging issues and ensure RA inputs, also part of risk / crisis management team

5. Develop multinational and global RA strategy for various products and optimize efforts and resources

6. Complete & accurate updates to top Management about changing Regulatory environment & options. Inform possible novel RA strategies in line with company business goals

7. Facilitate & Ensure lifecycle management activities, evaluate market viability of products

8. Active participation in Agency Audit & CAPA formulation, due diligence of dossiers

9. Active participation in all QMS related activity and also inputs to product Development.

10. Shall guide the team in preparing strategy to answer the queries related to ANDA/DMF received.

Key behavioral competencies

1. High level of integrity & ethics.

2. Command on regulatory knowledge of Finished Dosage Forms as well as API.

3. Analytical ability & Diplomatic sensitivity: draw sound conclusions based on analysis of information and experience

4. Skills to manage resources and inculcate values in team

5. Encourage team work through strong leadership

6. Non emotional problem solving and value added negotiation skills

7. Strategic networking skills

8. Should be able to co-ordinate with various manufacturing plants in gathering the necessary data required for filing with regulatory agencies.

9. Should have good decision making ability.

10. Shall involve frequent travelling to manufacturing plant and R&D.