Merck Senior Scientist, Regulatory Affairs- Chemistry. Manufacturing and Control 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 the Associate Director/Director, the Senior Scientist is responsible for implementing Chemistry, Manufacturing and Control (CMC) regulatory strategies for assigned pharmaceutical 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 commercial products. Primary responsibilities include, but are not limited to:
Provide input to global product and project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify 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.
Liaise with our Manufacturing Division and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product lifecycle.
Identify and communicate potential regulatory issues to Global Regulatory Affairs and Clinical Safety (GRACS) CMC management, as needed.
Education Minimum Requirements:
- B.S. in a 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:
At least two (2) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing or a related field.
The candidate must be proficient in English; additional language skills are a plus.
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 ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
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 on business commitments and project timelines.
Preferred Experience and Skills:
- A candidate with experience in CMC post-approval lifecycle management and/or strong active pharmaceutical ingredient (API) expertise is preferred.
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.
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R60388
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