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Associate Director, Regulatory Affairs

4 months ago

Plymouth Meeting, United States Organon Full time

Job Description The Position The Associate Principal Scientist is responsible fordeveloping andimplementing Regulatory Chemistry, Manufacturing and Controls (CMC) strategies forassignedsmall molecule products in accordance with global regulations andguidance's, andCompany procedures. The Associate Principal Scientist will lead thepreparation and submission of CMC dossiersfor life-cycle maintenance submissions, original registrations, and post-approval changes. The incumbent may manage a team of one to two individual contributors and/or outsourcing partners in supportof projectexecution. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as-needed basis. Responsibilities Serve as theCMC Product Leadfor assigned products and beaccountable for the delivery of all regulatory milestones forassignedproducts through the product lifecycle.

Lead development and execution of global product and project regulatory strategies by ensuring robust assessment of CMC changes, identificationofglobalregulatory 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,toproduct in-license/due diligence review, product divestment, and product withdrawal.

Collaborate with our Company's 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, registrationrenewals, 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,communicateand escalatepotential regulatory issues to Organon Regulatory CMC management, as needed.

Required Education, Experience and Skills Bachelor’s degree, in a science, engineering,or a related field - Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biologyor Biochemistry - with at least seven years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR Advanced degree (MS, MBA, Ph.D., PharmD) - minimum of four years of relevant experience including biological/pharmaceutical research, manufacturing,testingor a related field.

Strong negotiation, interpersonal, written/oral communication and fluent in English language.

Ability to lead by influence and work effectively in matrix organizational structures.

Project Management.

Good understanding of change management projects.

Proven experience in critically reviewing detailed scientific informationto 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 generateinnovative 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 and Skills Degree in pharmacy, biopharmaceutics, analytical chemistry, organic chemistry, chemical engineering, or a related discipline.

Experience in Regulatory CMC post-approval lifecycle management.

Direct experience in Regulatory CMC.

OCMC 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. US and PR Residents Only If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at

staffingaadar@organon.com

. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law. 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. 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. 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

Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1 Requisition ID: R526635

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