Associate Director - Regulatory Affairs Cmc

Associate Director - Regulatory Affairs Cmc
Company:

Merck Gruppe Msd Sharp & Dohme


Associate Director - Regulatory Affairs Cmc

Details of the offer

We are one company, Merck & Co., Inc., Kenilworth, New Jersey, USA but we operate under two different corporate brand names. We are known as Merck & Co., in the United States, Canada & Puerto Rico. We are known as MSD outside the United States, Canada & Puerto Rico. Associate Director - Regulatory Affairs CMC Location Platina, Mumbai, India Job Type Full time This site is for Residents of Europe, Middle East, Africa, Latin America & Asia Pacific. Residents of the United States, Canada & Puerto Rico, please click here . Job Description We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. 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. Role Summary The Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance’s, and our procedures. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial products. The Associate Director may manage a team of 2 to 4 individual contributors in support of project execution. Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. Key Responsibilities: Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. Collaborate with Global CMC, Our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance. Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed Technical Skills: Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. Leadership Skills: Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Demonstrated effective leadership, communication, interpersonal and negotiating skills. Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines. Qualifications Bachelor in Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry. Minimum 12 – 14 yrs of Industry Pharmaceutical industry experience out of 6 years’ experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics. The candidate may be required to travel to our other sites on a need basis. Who we are … Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. What we look for … In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth . INVENT. IMPACT. INSPIRE. Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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: R59227 Email this job to: Your Name About Us We are one company, Merck & Co., Inc., Kenilworth, New Jersey, USA but we operate under two different corporate brand names. We are known as Merck & Co., in the United States, Canada & Puerto Rico. We are known as MSD outside the United States, Canada, & Puerto Rico. Not ready to apply? Join our Talent Community to stay connected and receive updates on the latest job opportunities. Sign up Now Get tailored job recommendations based on your interests. This careers website is intended for Residents of Europe, Middle East, Africa, Latin America & Asia Pacific. Residents in the United States, Canada & Puerto Rico, please visit this Careers website . Information on this site is for the purpose of presenting career opportunities at our organisation and give our audience a view of our culture, diversity and growth opportunities. Our Company is an equal opportunity employer, proudly embracing diversity in all of its manifestations. This website is maintained by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.


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