Merck Associate Director, Global Regulatory Vaccines CMC (Associate Principle Scientist) in Kenilworth, New Jersey
Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Reporting to the Director or Executive Director, the Associate Principle Scientist is responsible for creating and implementing Chemistry, Manufacturing and Controls (CMC) regulatory strategies for our Company's vaccine products in accordance with global regulations and guidance and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products.
Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
Manage execution of CMC documentation including Investigational New Drug (IND)/Clinical Trial Application (CTA), New Drug Application (NDA/Biologics Licensing Agreement (BLA)/Marketing Authorization Application (MAA), post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Accountable for the delivery of all regulatory milestones for higher complexity products through the product life cycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures.
Prioritize execution of submissions and lead opportunities to maximize submission efficiency.
Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of our Company vaccine products worldwide.
Identify appropriate opportunities for, lead preparation for and execution of consultation with Health Authorities.
Conduct all activities with an unwavering focus on compliance.
Education Minimum Requirements:
- Bachelor's degree in a biological science, engineering, or a related field (advanced degree preferred).
Required Experience and Skills:
At least ten (10) years of relevant experience (5 years with an advanced degree), including biological/vaccine research; manufacturing, testing, or licensure of biological/vaccine products; or related fields.
The candidate must be proficient in English; additional language skills are a plus.
At least three (3) years of Regulatory Affairs CMC experience.
Preferred Experience and Skills:
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are 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, with 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.
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.
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.
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 .
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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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.
Flexible Work Arrangements:
1st - Day
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Number of Openings:
Requisition ID: R45904