Glenmark Pharmaceuticals Limited [Glenmark] is an India-based growing pharmaceutical company headquartered at Mumbai [formerly, Bombay]. Incorporated in 1977, the Company is focused on the manufacture and marketing of formulation products and active pharmaceutical ingredients [API] in India as well as globally and enjoys a diversified and growing presence in regulated and developing international markets. Over the past five years, the Company has also catalyzed its growth through investment in dedicated research and development including cutting-edge New Chemical Entity [NCE] research.
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At Glenmark, our people are encouraged to discover and follow their own unique path of career development.
Aligning individual aspirations to business goals, we offer a range of opportunities that allows our talent to develop both breadth and depth of experience. This includes cross-functional movements, stretch assignments, and international stints.
We recognize high performance & drive for results through fast track career paths & other developmental opportunities. Each team member is supported on their growth journey through continuous learning interventions.
Position: Senior Manager – Regulatory (Post-approval Life cycle Management)
Location: Mumbai, Maharashtra
- The objective of the role is to lead the team for strategic evaluation of post-approval changes for the US market as per regulatory guidelines.
- The incumbent would be responsible for all PLCM activities for US Market like Supplements – PAS, CBE-30, CBE-0, and Annual Reports.
- Would also be responding to Health authority deficiencies raised on post-approval submissions.
- Experience of 11-13 years preferred, with mandatory managerial experience
- Strategically evaluate all change proposals (site transfer/alternate process API/alternate API vendors/excipients/container closure vendor/pre-launch changes or any other change to approved dossier) received from various stakeholders and provide guidance in terms of filing strategy.
- Planning, and ensuring timely submission of various supplements by providing guidance to the team for submission of various supplements i.e. PAS, CBE-30, and CBE-0 and other general correspondence.
- Technical evaluation of the deficiency received from FDA and coordination with various responsible stakeholders to ensure quick turnaround time for replying to Complete response letters/Information requests received on supplements from USFDA. Also, evaluation of response received from R&D/Plant to ensure that the responses submitted are technically responded to meet the FDA’s requirements and in turn, result in faster approval of the proposed change.
- Monitoring of timely submission of Annual Reports (AR) to the agency within two months of the anniversary date and also ensure that it meets internal timelines as captured in the AR database.
- Provide support to ensure patient/pharmacist queries received from the Pharmacovigilance team are responded in a timely manner.
- Ensure regulatory compliance at all levels of operations. Coordination for USP forum monograph submission.
- Provide support to devise best strategies for various cost-benefit programs (alternate process/alternate API/excipient/container closure vendor/site transfer/any other changes to approved dossiers) run across the organization for US market
- Maintenance of various regulatory database to capture the complete history of the product.
- Keep updated with various guidelines from Health authorities
Desired Knowledge and Skills
- Sufficient knowledge and experience in post-approval life cycle management of the US.
- Planning and leading teams on PLCM activities like Supplements – PAS, CBE-30, CBE-0, and Annual Reports/Variations for emerging markets
- Sound knowledge in reviewing formulation and Analytical documents with respect to various dosage forms like oral solids/topical/respiratory and injectables dosage forms.
- Good written and oral communication skills. Command over written and oral English
- Should have team handling skills
Experience: 11-15 Years
Salary: 18,00,000 to 20,00,000 INR CTC/PA
Mr. Varun Jain
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