Senior Specialist - Regulatory Affairs, CMC - Small Molecule Post-Approval Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Reporting to the Associate Director, the Sr. Specialist is responsible for implementing 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 Merck Manufacturing Division (MMD) 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
- 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.
- 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
- Technical 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).
- Leadership Skills:
- 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.
- A candidate with experience in CMC post-approval lifecycle management and strong API expertise is preferred
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Regulatory Affairs - CMC
Job Title:Sr. Spclst, Regulatory Affairs-CMC
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Number of Openings: 3
Shift (if applicable): N/A
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Regulatory Affairs, Pharmacy, Engineer, Law, Scientific, Legal, Healthcare, Engineering