Bachelor's degree in a science or engineering field with 7+ years of relevant experience, or an advanced degree with 4+ years of experience.
Proficient in English; additional language skills are a plus.
Experience in critically reviewing scientific information for technical merit and clarity.
Superior oral and written communication skills in multicultural settings.
Strong understanding of manufacturing, analytical, and quality assurance fields.
Ability to generate innovative solutions to complex regulatory problems.
Demonstrated leadership and interpersonal skills.
Responsibilities
Serve as the CMC Product Lead for assigned products, ensuring delivery of regulatory milestones.
Lead development and execution of global regulatory strategies, assessing CMC changes and identifying requirements.
Execute regulatory strategies by authoring and reviewing CMC submission components and documentation.
Provide regulatory leadership for product in-licensing, divestment, and withdrawal.
Collaborate with manufacturing and supply teams to ensure regulatory compliance in change management.
Manage CMC documentation for post-approval supplements and health authority responses.
Assess and communicate potential regulatory risks, proposing mitigation strategies.
Benefits
Flexible work arrangements including flex time and hybrid options.
Full Job Description
Job Description
The Position
Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small molecule or combination products in accordance with global regulations and guidances, and Organon procedures. The Associate Principal Scientist will lead the preparation and submission of CMC dossiers for life-cycle maintenance submissions, original registrations, and post-approval changes. The incumbent may manage a team of 1 to 2 individual contributors and/or outsourcing partners in support of project execution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis.
Responsibilities
Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of 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.
Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
Collaborate with Organon Manufacturing & Supply colleagues and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product lifecycle.
Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as needed.
Required Education, Experience & Skills
Bachelor's degree, in a science, engineering, or a related field. Fields of study include Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least 7 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 4 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.
Proven experience in critically reviewing detailed 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 superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, communication, interpersonal and negotiating skills.
Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Preferred Experience & Skills
A candidate with experience in Regulatory CMC post-approval lifecycle management for small molecule and Combination product is preferred.
OCMC
Secondary Language(s) Job Description
Annualized Salary Range (US)
$125,400.00 - $213,100.00
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: Flex Time, Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: 1
About Organon
Organon is a global pharmaceutical company that develops and manufactures prescription medicines, vaccines, and animal health products. The company is focused on improving the health and well-being of people and animals around the world. Organon has a diverse portfolio of products that includes treatments for women's health, oncology, and fertility. The company is committed to sustainability and has set ambitious goals to reduce its environmental impact and improve access to healthcare in underserved communities.
