Prin. Scientist, Regulatory Affairs-CMC

Job Description

The position

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

CMC OSS SITE LEAD

The Principal Scientist, Site Chemistry Manufacturing and Controls (CMC) is part of the Organon Regulatory CMC organization and supports Site CMC & Conformance activities within the designated manufacturing site or within the external manufacturing network. Reporting to the Director Site CMC, the Principal Scientist will support CMC conformance programs for Organon products to ensure that Organon products are manufactured, tested and released in accordance with the approved Marketing Authorizations. This includes providing support for product change control development, including assessment of change control information from the Organon Manufacturing & Supply (OMS) sites, representing Regulatory CMC on Site Change Review Boards, providing regulatory CMC input into inquiries and working with headquarters CMC teams to facilitate preparation of global regulatory CMC submissions. Additionally, the Principal Scientist leads the Site CMC team at the Oss site and serves as a member of the Site CMC Leadership Team.

Responsibilities:

Core function – manage the interface between the Manufacturing Site and Regulatory CMC to maintain product regulatory conformance. Specific responsibilities include:

• Supports both Oss sites (Kloosterstraat 6 and Vollenhovermeer 2) for biotechnological drug substances and parenteral products manufactured at these locations.
• Support the External Manufacturing Sites that manufacture Drug Substance and Drug Product for Pharmaceutical and Parenteral Products, including Biotechnological products, for Drug Products handled at the Oss site.
• Perform the role of Authorized Signatory for N.V. Organon by execution of documents required for Regulatory Affairs and related activities.
• Ensure that the information included in global regulatory submissions/filings is aligned to plant information and supports future compliance and maintenance.
• Ensure that regulatory-impacting changes are correctly identified and assessed for regulatory impact. Work with other CMC teams to ensure that regulatory post-approval changes are managed & processed efficiently through to last market approval and implementation.
• Ensure that regulatory information is correctly maintained, updated and interpreted, in Regulatory Information systems and tools.
• Work with site Quality, Technical and Supply Chain functions to provide regulatory submission status, when requested to ensure that product released to a market complies to the relevant Marketing Authorization.
• Act as a point of escalation for regulatory compliance or related issues that may arise at the manufacturing site and serve as a Subject Matter Expert in the management and resolution of any such issues.
• Represent the CMC organization and provide regulatory input to Site teams/committees, including Change Review Boards, Quality Councils, product and investigation teams.
• Manage Site CMC Oss team. Holds line management and people management responsibilities for the Oss Site CMC team supporting Organon’s Oss manufacturing sites and external manufacturing network. Oversee team performance and ensure objectives are achieved across the organization.

Other activities

• Coordinate submission component authoring (mainly for post-approval CMC changes) with site subject matter experts and CMC product leads.
• Support product teams to coordinate responses to Health Authority (HA) questions on submissions impacting manufacturing sites.
• Obtain technical data, reports, and ancillary documents to support regulatory CMC submissions and response to Health Authority questions.
• Participate in major project teams where there will be significant regulatory CMC impact, e.g. product transfer teams, new product introductions, etc.
• Ensure that Health Authority CMC commitments are captured in site commitment tracking and monitor actions to fulfil them in accordance with committed timelines.
• Support Health Authority notifiable events and site investigations.
• Support Health Authority inspections of the manufacturing site.

Required Education, Experience, and Skills

• The candidate must possess a Bachelor’s degree or higher in science, (e.g. pharmacy, chemistry, engineering, biotechnology, microbiology, biomedical sciences, etc.) with a minimum of 10 years of experience in the pharmaceutical industry in a regulatory, compliance, technical services or quality role; post-graduate degree preferred.
• The candidate must have a minimum of 5 years’ experience in CMC Regulatory Affairs for pharmaceutical and biotechnology products.

• The candidate must have a good understanding of and experience working in a busy commercial manufacturing organization. He / she must be able to effectively manage the competing demands of site and corporate stakeholders.

• The successful candidate will demonstrate effective problem-solving skills, be detail oriented and able to prioritize multiple tasks.
• Must have excellent interpersonal skills and a proven ability to communicate effectively in both a written and verbal format.
• The candidate must be proficient in English; additional language skills are a plus.
• Ability to influence and work both independently and collaboratively in a team structure.
• Proven ability to be highly adaptable and work well under pressure.
• The candidate will be required to travel on a periodic basis.

Secondary 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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

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.

Annualized Salary Range

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1