Markets – US / EU
Educational Qualification – M.Pharm
Experience – 6 to 7 Years experience in any of these US/EU Markets is a must
Job Location – Baroda
Roles and Responsibilities
Responsible for preparation, review and submission of good quality dossiers thereby enabling faster approvals and timely launch; also ensure business continuity through timely life-cycle management.
Candidate should have experience ofUS / EU marketpre & post approval ANDA Submissions
Area of Responsibility:
1. New Submissions: Work with Product Development (For Drug products) & other CFT (within and outside R&D) to ensure that sufficient and timely regulatory information and controls are included during design and development of drug products as per country specific regulatory requirements.
a. Provide feedback in terms of document requirements & regulatory filing strategy during development of new DF (Drug formulation).
b. Preparation and submission of good quality dossiers thereby enabling faster approvals and timely launch.
c. Assist in preparation and submission of meeting packages/scientific discussion with Agency related to product development (if required).
2. Approval: Prepare and submit timely response to
deficiencies enabling approval of products.
3. Lifecycle Management of approved drug products:
a. Timely preparation and submission of annual reports/renewals.
b. Evaluation, preparation and submission of changes through variations, supplements etc that impact product supplies.
c. Regulatory Compliance- Ensure timely
implementation of regulatory decisions for change management and other activities in DF plants.
d. Ensure reposition of comprehensive product information into central repository.
Send resume on Rosemary.email@example.com