Prin. Scientist, Regulatory Affairs-CMC

Organon LLC; Oss; On-site; EUR 150,000 - 190,000; Full time

Benefits offered by this job

Flexible Work Arrangements: Hybrid

Job summary

Organon is seeking a Principal Scientist, Site Chemistry Manufacturing and Controls (CMC) for the Oss site. You will lead the Site CMC team, ensuring regulatory conformance and alignment with global submissions, as well as representing Regulatory CMC on site change boards.

You will coordinate post-approval CMC changes, support health authority inquiries, and partner with headquarters CMC teams to drive compliant manufacturing and release of products at the Oss site and through external networks.

Qualifications

• Bachelor's degree or higher in science with 10+ years in pharma regulatory/compliance roles.
• 5+ years’ experience in CMC Regulatory Affairs for pharma/biotech products.
• Experience in busy commercial manufacturing organizations and regulatory submissions.
• Strong problem-solving, prioritization, and communication skills.
• Proficiency in English; travel may be required.

Responsibilities

• Manage interface between manufacturing site and Regulatory CMC to ensure conformance.
• Lead Site CMC Oss team and participate in Site CMC Leadership Team.
• Coordinate regulatory submissions, post-approval changes, and health authority inquiries.
• Act as Authorized Signatory for Organon and provide regulatory input to cross-functional teams.
• Support health authority inspections and notifiable events at the Oss site.
• Collaborate with global CMC teams and external manufacturing networks.

Skills

CMC Regulatory Affairs

Regulatory compliance

Problem solving

Interpersonal skills

English proficiency

Education

Bachelor's degree or higher in science (e.g. pharmacy, chemistry, engineering, biotechnology, microbiology, biomedical sciences, etc.)

Post-graduate degree preferred

Job description

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.
• 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.

Annualized Salary Range

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 Details

• 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

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.