Associate Principal Scientist – Regulatory CMC, Medical Device and Combination Product (MDCP)

9000 Organon LLC; Florham Park (NJ); Hybrid; USD 125,000 - 213,000; Full time

Job summary

Organon seeks an Associate Principal Scientist to lead regulatory CMC strategies for assigned small molecules. You will head the preparation and submission of CMC dossiers for lifecycle maintenance, original registrations, and post-approval changes, coordinating a small team or outsourcing partners as needed.

You will guide global regulatory strategy, assess risks, and ensure documentation meets regulatory expectations while collaborating with Manufacturing & Supply to support product continuity

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Advanced degree (MS, MBA, Ph.D., PharmD) with relevant experience.
• Proficient English; additional languages a plus.

Responsibilities

• Serve as the CMC Product Lead for assigned products and deliver regulatory milestones.
• Lead development and execution of global regulatory strategy(s) for CMC changes.
• Develop, author, and review CMC submission components for life-cycle and post-approval activities.
• Provide regulatory leadership for in-license/due diligence and product during divestment or withdrawal.
• Collaborate with Manufacturing & Supply and external partners on compliant change management.
• Manage CMC documentation including post-approval supplements and annual reports.

Skills

CMC strategy

Regulatory submissions

Regulatory affairs

Leadership

Written communication

Education

Bachelor's degree in science/engineering

Advanced degree (MS/MBA/PhD/PharmD)

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 escalates 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.

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.

US and PR Residents Only

For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule

Salary and Benefits

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.

• Annualized Salary Range (US) $125,400.00 - $213,100.00
• Annualized Salary Range (Global)
• Annualized Salary Range (Canada)

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.

• 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

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.