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

Job Description

The Position

Reporting to the Business Processes Lead, the Senior Scientist will be responsible for managing integrated Chemistry, Manufacturing and Controls (CMC) submission deliveries in alignment with departmental goals. This role provides vital support for the planning, preparation, and release of regulatory submissions. Key responsibilities include data administration such as collection, analysis, timeline management, tracking deliverables, and maintaining CMC systems and processes in collaboration with CMC Franchises. The Senior Specialist ensures the accuracy and visibility of CMC timelines and data, overseeing processes from submission authorization through implementation.

Responsibilities

• Planning & Coordination: Work with CMC Scientists to gather and organize data for regulatory submissions strategy. Ensure that regulatory information is accurately maintained, updated, and interpreted within regulatory systems and tools. Partner with Organon Manufacturing and Supply and Organon R&D stakeholders to ensure smooth execution of business processes.
• CMC Submission Project Management: Support the progression of CMC submissions through all stages (authorization, assessment, execution, implementation), acting as a Subject Matter Expert in Organon’s submission planning tool. Manage timelines and deliverables in collaboration with cross-functional CMC teams.
• System Maintenance & Data Management: Maintain and utilize Organon CMC systems to ensure regulatory conformance and operational compliance. Actively participate in system Change Agent meetings, addressing system irregularities identified by the Regulatory CMC team.
• Cross-Functional Coordination: Ensure visibility into project constraints, collaborating with international and external stakeholders as necessary.
• Continuous Process Improvement: Contribute to the development and enhancement of business processes, tools, and metrics to improve efficiency and data accuracy.
• Documentation & Submission Support: Format, finalize, and upload submission documents into regulatory systems, ensuring readiness for submission.
• Additional Project Support: Provide support on other CMC-related projects as required.
  
  

Qualifications

Required Education, Experience, and Skills

• Bachelor’s degree, in a science, engineering, or a related field. Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least 4 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR
• Advanced degree (MS, MBA, Ph.D., PharmD) with at least 2 years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
• Direct experience in Regulatory CMC is preferred.
• Skills: Strong project management abilities with a proven track record of managing competing tasks and priorities. Excellent interpersonal, written, and verbal communication skills, with the ability to work collaboratively across functions in a matrixed environment. Capable of working both independently and as part of a team.
  
  

Preferred Education, Experience, And Skills

Preferred Qualifications: Exposure to regulatory affairs, project management methodologies (e.g., PMP, Six Sigma), and proficiency in planning and data tools (e.g., MS Project, MS Excel).

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Search Firm Representatives Please Read Carefully

Organon LLC, 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.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status

Regular

Relocation:

No relocation

VISA Sponsorship

No

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

10%

Flexible Work Arrangements

Hybrid

Shift

Valid Driving License:

Hazardous Material(s)

Number of Openings:

1

Requisition ID:R534864