Associate Director, Regulatory Affairs

Job Description

Associate Director – Regulatory Affairs

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
 

Key Responsibilities:

• Responsible for products Oncology, Vaccine, imported and local manufactured CVM products. Support I managing licenses obtained from SFDA.
• Review & submission of quality dossier/documents to respective authorities. Planning and strategy and its implantation, for site registration, Import License their renewals, variations , life cycle maintenance etc.
• Govt. Lab testing; DCGI office and SFDA: Responsible and managing relationships with central, state licensing authority and with testing labs for batch release of vaccines.
• Support other regulatory function TA’s approval from DCGI for new products, site registration, Import License their renewals, variations, life cycle maintenance etc.
• Neighboring markets: QC of submission dossier, planning and strategy and its implantation, Marketing approval from regulatory agency,  site registration, Import License their  renewals , variations , life cycle maintenance etc. for neighboring countries for responsible TA
• Regulatory Compliance: Non conformities,  Artworks specific to TA , Orion, Red Compass, BWEL, USPT , BDLM, PSPM, iCMC  Surveys, etc
• In the discharge of your responsibilities, you will be required to undertake such other jobs as may be assigned to you by the Management from time to time.

Qualifications and Skills

• 15 year’s relevant experience in regulatory affairs with strong knowledge of regulatory
• Proven leadership qualities including the ability to identify talent, coach and develop.
• Excellent decision making and networking skills.
• Ability to work in uncertainty and complexity.
• Good communication skills in written and spoken English is preferred.

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

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