Regulatory Affairs Head - Strategy & Bus Ops

Head Regulatory Affairs Branded Therapeutics – Strategy and Business Operations

One of our client which is a large Indian Pharma House is looking for Head Regulatory Affairs Branded Therapeutics – Strategy and Business Operations based at Mumbai.

Someone having fair understanding of new molecules both NCEs (new chemical entity) and NBEs (new biological entity).

Designation:- Head Regulatory Affairs Branded Therapeutics – Strategy and Business Operations

Qualification:- Good first degree in the physical pharmaceutical or biological life sciences

Team Handling:- Need a mature professional who has handled large teams and proven leadership skills.

Job Role & Responsibilities:

- Lead, manage and develop the strategic Regulatory aspects of Branded Therapeutics business.

The role focuses on the development of new products and the maintenance of existing licenses for Rest of World Markets in the following therapeutic areas:

- Respiratory

- Oncology

- Dermatology

- Cardiovascular / Metabolism

1.Responsibility for leading the delivery of the regulatory strategy for new branded therapeutics products including input into development strategies and decisions

2.Lead regulatory activities to obtain product approvals in RoW markets, including regulatory co-ordination of successful GMP inspections of finished product/api manufacturing facilities

3. Be accountable for the success of the India RA function, including preparing Clinical Trial and marketing authorisation applications and other submissions, participating in interactions with the DCO and the CDSCO, IND and NDAC committees

4.Responsible for developing and maintaining information included in Regulatory Databases including Register

External Interface:-

- Regulatory, Clinical, Quality & Pharmaceutics’ Consultants Contract companies for specific projects, CDSCO.

Knowledge and Skills (Functional / Technical)

- Broad exposure to branded therapeutics drug development

- Familiar with Emerging Markets regulatory regulations and future trends

- Familiar with CDSCO requirements

- Familiarity with computer software programs including Extedo cCTD Manager, Sharepoint and Register preferred

Interested candidates can share their profiles at trupti@mancerconsulting.com

Trupti C