Sr. Specialist, Regulatory Affairs CMC-REG002922
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. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck’s Regulatory Affairs organization helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time.
Reporting to an Associate Director or Director, the Senior Specialist is responsible for implementing 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 IND/CTA, original NDA/MAA, agency background packages, responses to health authority questions, and post-approval submissions per established business processes and systems.
- Liaise with MMD and MRL 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 GRACS CMC management, as needed
- Conduct all activities with an unwavering focus on compliance, attention to detail and following all procedures associcate with Merck regulatory systems.
- 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.
Please note, relocation assistance is not provided for this position.