Principal Scientist, Regulatory Affairs - CMC

Job Description

Although one or more potential candidates for this position have been identified, we will consider applications from any interested applicants.

The Position 

Reporting to the Executive Director, Head of General Medicine Portfolio, Regulatory Chemistry, Manufacturing & Controls (CMC), the Principal Scientist, Team Lead is responsible for providing strategic Regulatory CMC leadership for the Cardiovascular portfolio within the General Medicine organization. This role is accountable for developing and executing global Regulatory CMC strategies across assigned products to ensure successful product lifecycle management, including original registrations, post-approval changes, and ongoing regulatory maintenance, in accordance with global regulations, guidance, and Organon procedures. The Principal Scientist is accountable for delivery of all regulatory milestones and alignment with portfolio strategy and business objectives. In addition, this role has direct people management responsibility, including leading, coaching, and developing a team of Regulatory CMC professionals (individual contributors and/or managers). The incumbent is responsible for building organizational capability, fostering a high-performing and inclusive team culture, and ensuring effective resource planning and execution across the portfolio. The Principal Scientist will lead the preparation and submission of CMC dossiers and oversee execution of regulatory deliverables across lifecycle activities. The role also partners cross-functionally with R&D, Manufacturing & Supply, Quality, and external partners to ensure compliant and efficient implementation of regulatory strategies. The incumbent may also contribute to broader organizational initiatives, including portfolio prioritization, process improvements, and talent development, as needed.

Responsibilities

• Serve as a CMC Team 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 strategies 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 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 Research & Development, Manufacturing & Supply colleagues, and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.  

• Direct 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 leadership 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. 

• Manage 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

• 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 ten (10) years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.   5 years with an advanced degree.  Minimum 5 years working in Regulatory CMC, with progressive experience leading global programs.

• 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 Education, Experience & Skills

• A candidate with experience in Regulatory CMC post-approval lifecycle management is preferred 

Secondary Language(s) 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.

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Applicable to United States Positions Only:  Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job.  Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience.  The applicable salary range for this position in the U.S. is stated below.  Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

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

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

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