Senior Scientist, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC)

Organon•Florham Park, NJ

3d•Hybrid

About The Position

The Senior Scientist implements Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or biological products in accordance with global regulations, guidances, and defined regulatory strategies. The role prepares and reviews information for development of regulatory CMC dossiers for commercial products, supports products throughout their lifecycle, and works with Organon Manufacturing & Supply colleagues and external partners to maintain regulatory conformance.

Requirements

Bachelor’s degree in a science, engineering, or related field, such as Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry, and at least 4 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field; OR an advanced degree (MS, MBA, Ph.D., or PharmD) and at least 2 years of relevant experience in those areas.
Proficiency in English.
Experience reviewing scientific information to assess technical merits and the suitability of scientific rationale, and ensuring information is clearly presented with conclusions adequately supported by data.
Demonstrated oral and written communication skills, including the ability to communicate issues succinctly and logically, and strong listening skills.
Demonstrated understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.
Ability to generate innovative solutions to problems and work and communicate effectively with key stakeholders.
Flexibility in responding to changing priorities and unexpected events.
Ability to handle multiple priorities and balance work to achieve business goals.
Demonstrated effective leadership, communication, and interpersonal skills.

Nice To Haves

Direct experience in Regulatory CMC.
Additional language skills.

Responsibilities

Provide input to global product and project regulatory strategies by assessing CMC changes, identifying global regulatory requirements, and evaluating supporting documentation for acceptability and potential risks.
Lead the development, authoring, and review of CMC submission components and documentation for post-approval supplements, annual reports, registration renewals, and responses to health authority questions.
Liaise with Organon Manufacturing & Supply colleagues and external partners to support compliant change management and regulatory conformance.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver regulatory milestones for assigned products across the product lifecycle.
Identify and communicate potential regulatory issues to Organon Regulatory CMC management as needed.