Merck Senior Regulatory Scientist in Rahway, 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 an Associate Director or Director, the Senior Specialist is responsible for implementing Chemistry, Manufacturing and Control (CMC) regulatory strategies for assigned pharmaceutical pipeline or recently registered products in accordance with global regulations, guidances and defined regulatory strategies. The Senior Specialist is responsible for the preparation and review of information required for development of regulatory CMC dossiers for assigned products. Primary responsibilities include, but are not limited to:
Provide input to global regulatory strategies by performing assessments of CMC changes associated with investigational products, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
Manage execution of CMC documentation including Investigational New Drug (IND)/Clinical Trial Application (CTA), original New Drug Application (NDA)/Marketing Authorization Application (MAA), agency background packages, responses to health authority questions, and post-approval submissions per established business processes and systems.
Liaise with our Manufacturing Division and our Research & Development Division partners in support of assigned products.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product lifecycle from IND to post-approval changes.
Identify and communicate potential regulatory issues to Global Regulatory Affairs Clinical Safety (GRACS) CMC management, as needed.
Conduct all activities with an unwavering focus on compliance, attention to detail and following all procedures associated with our Company's regulatory systems.
Education Minimum Requirements:
- B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
Required Experience and Skills:
Experience in reviewing 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 oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Capability to handle multiple priorities and balance work to achieve business goals.
Demonstrated effective leadership, communication, and interpersonal skills.
At least 3-5 years of relevant experience, including CMC (direct or indirect), biological/pharmaceutical research; manufacturing, testing or a related field.
The candidate must be proficient in English; additional language skills are a plus.
Preferred Experience and Skills:
Experience with investigational and late stage development compounds.
Demonstrated oral and written communication skills in multicultural settings.
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.
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Number of Openings:
Requisition ID: R43957