Associate Principal Scientist, Regulatory Affairs Chemistry, Manufacturing and Controls (CMC)

Job Description

The Position

Reporting to the Director in Organon Regulatory Chemistry, Manufacturing and Controls New Products,the Associate Principal Scientist (Associate Director) is responsible for Regulatory Chemistry, Manufacturing and Controls (CMC) aspects of clinical phase through market product registration for the assigned biological / biosimilar / small molecule products in accordance withglobalregulations,guidance'sand defined regulatory strategies. These products may be internal or acquired or licensed externally as a key component of the company growth strategy. The organization is envisioned to focus on innovative products addressing women’s health across diverse therapeutics including Biosimilars and will encompass late-stage development products and commercially approved compounds. The Associate Principal Scientist may also support project team goals and organizational initiatives, on an as needed basis. Primary responsibilities include, but are not limited to :

Responsibilities

Partner with Research & Development, Manufacturing & Supply, Business Development and Commercial to embed an adaptable process with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and initial product registration activities in an efficient, agile manner.

Provide Regulatory CMC and oversight in developing global Regulatory CMC strategies and executing submissions related to diverse late-stage development and / or licensed in products. This includes documenting regulatory CMC strategies, leading preparation and authorship of applicable IND / CTAs / NDA / BLA and post-approval activities, Health Authority Regulatory CMC engagement strategy, Agency Background Packages, participating in Agency meetings on CMC topics, and executing global initial marketing applications with a line of sight to long-term robust supply. This role will directly support projects and / or coordinate with Regulatory CMC scientists in the Organon franchise teams.

Lead development and execution of regulatory CMC strategies to ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during development and defining regulatory CMC requirements, demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, utilizing regulatory intelligence, and incorporating knowledge of the changing regulatory environment.

Embed regulatory CMC activities within product development plans that outlines the requirements for the product, the development plan and associated regulatory approval timeline and how this will be managed.

Responsible to ensure regulatory requirements are met and systems / processes are executed in a manner to provide visibility to accurate regulatory information to enable proper product control. Ensures appropriate reviews, approvals and systems are in place to maintain the quality of scientific, technical and regulatory information within CMC submissions, responses and correspondence.

Identify,communicate,and 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. Fields of study includePharmacy, Chemistry, Chemical Engineering,Biology,Microbiology, Virology, Molecular Biology, or Biochemistrywith at least seven years of relevant experience including biological / pharmaceutical research, manufacturing,testingor a related field OR

Advanced degree (MS, MBA, Ph.D., PharmD) with at least five years of relevant experience including biological / pharmaceutical research, manufacturing,testingor a related field.

The candidate must be proficient in English; additional language skills are a plus.

Proficient in authoring high-quality CMC documentation for Health Authority submissions, establishing and applying CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.

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.

Technical Skills

Evaluation of SME technical documentation for completeness and sufficient details in order to make accurate regulatory assessments through utilization of current global regulatory guidance’s.

Experience in reviewing scientific information to assesstechnicalmerits and suitability of scientific rationale to ensure information ispresented clearly and conclusions are adequately supported by data.

Familiar with regulatory guidelines for product post-approval change management and data requirement.

Demonstrated oral and written communication skillsand theability to communicate issues in a succinct and logical manner. Strong listening skills.

Demonstrated understanding of related fields (e.g.,pharmaceuticalmanufacturing, analyticaltesting,and qualityassurance).

Leadership Skills

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.

Managing multiple projects to ensure on-time deliverables and timely submissions to ensure product supply continuity.

Preferred Experience and Skills

A candidate with experience in Regulatory CMC with demonstrated understanding of related pharmaceutical, biological or device operations (e.g., manufacturing, process development, analytical, and quality assurance) is preferred.

Direct experience in Regulatory CMC Biologics and / or authoring of regulatory documentation.

Device and / or combination product regulatory experience.

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.

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.

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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)

124,000.00 - $210,700.00

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 :

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

Flexible Work Arrangements :

Flex Time, Telecommuting

Shift :

Valid Driving License :

Hazardous Material(s) :

Number of Openings :

Requisition ID : R530282

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Salary : $124,000 - $210,700