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.

Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide. Who we are … We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for … Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
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: Regular Relocation: Domestic VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1
Requisition ID:R179195