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Senior Regulatory Scientist (REMOTE)

at Organon & Co. in Dover, Delaware, United States

Job Description

Job Description

Subject to applicable law, all prospective U.S. Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA) or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future-come be a part of it!

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Position Purpose:

+ Regulatory Affairs Liaison US (Senior Scientist) will support products in an assigned therapeutic area(s) as part of a regulatory team.

+ Responsible for providing regulatory support across all phases of development.

+ The individual will have excellent communication and collaboration skills and will work closely with a Director or Executive Director to help develop and implement strategy for registration of products in a variety of therapeutic areas and help manage regulatory submissions.

+ Responsibilities may encompass all aspects of planning and implementation of regulatory strategy and regulatory submissions.

+ Senior Scientist will report to a Director or Executive Director and will work with one or more Regulatory Liaison Directors in the assigned therapeutic area.

+ The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.

Primary Responsibilities:

Specific responsibilities (with coaching and managerial oversight) include, but are not limited to:

+ Assisting in Regulatory Agency communications and submissions, including but not limited to: marketing applications (NDAs, BLAs, sNDAs, sBLAs, etc.), requests for orphan drug and/or breakthrough designations and annual or other periodic reports.

+ The individual will also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.

+ Implementing strategy to develop Agency background packages and documents associated with Regulatory submissions for marketing applications.

+ Communicating with Agencies and attending Agency meetings as needed to assist the Director or Executive Director Liaisons.

+ Participating as an active member on the regulatory team.

+ The individual will attend cross functional meetings, as required, in collaboration with, and to assist the Director or Executive Director Liaisons.

+ Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy. Assist the Director or Executive Director liaisons in authoring of regulatory strategy documents.

+ Collaborating and communicating regulatory strategy, as needed, to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory CMC, as well as other functional areas (e.g., clinical research, safety assessment).

+ Support of Director or Executive Director liaisons in label development.

+ Assisting with process improvement initiatives.

+ Performing regulatory administrative activities as needed in support of the assigned TA.

Additional responsibilities and desirable characteristics:

+ Participate in projects outside of current responsibilities as needed to drive the organization forward to success.

+ Contribute to determining solutions outside of current responsibilities as needed and manage day-to-day operational issues outside of current responsibilities, as needed.

+ Work seamlessly with other R&D departments as well as commercial organization and manufacturing organizations.

+ Driver of innovative and creative solutions for achieving R&D goals and objectives in a high quality and cost-effective manner.

+ Must be able to support highly complex multiple activities simultaneously.

+ Must have proven track record to be able to think critically, strategically, independently and problem solve.

+ Must have high level of motivation, drive, and demonstration of our company’s leadership values.

+ Top notch interpersonal skills in difficult situations.

+ Driver of change and innovation.

+ Ability to work seamlessly with all levels of personnel.

+ Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.

Education Minimum Requirements:

+ Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.

+ Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 4 years of relevant experience in the pharmaceutical industry. Alternatively, a Master’s or other advanced degree with at least 2 years of relevant experience in pharmaceutical industry.

Required Experience and Skills:

+ Must have excellent communication skills (both oral and written)

+ Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.

+ Flexibility is required.

+ Strong scientific and analytical skills with attention to detail.

Preferred Experience and Skills:

+ Prior regulatory experience with any major regulatory agency is preferred.

+ Experience in clinical drug development is preferred. Depending upon previous work experience, a new Senior Scientist may require close managerial oversight and guidance as they gain and accumulate knowledge and gain exposure to programmatic regulatory issues.

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.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

Residents of Colorado: to request this role’s pay range: email: coloradopayact@organon.com

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 emai

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Job Posting: JC198882978

Posted On: Dec 03, 2021

Updated On: Jan 06, 2022