The Position
The Specialist, Regulatory Affairs supports regulatory activities to maintain existing registrations and obtain new marketing authorizations across Europe through Centralized, Mutual Recognition, Decentralized, and National Procedures. The role supports assigned products at local and/or European level and acts as a regulatory contact with Health Authorities.
Responsibilities
Ensure compliance of all regulatory activities with local Health Authority requirements and Organon policies.
Support preparation, submission, approval, and maintenance of Marketing Authorizations.
Manage post-approval activities including variations, renewals, PSURs, RMPs, labeling changes, and administrative updates.
Support preparation and submission of new Marketing Authorisation Applications (CP, MRP, DCP, NAP).
Coordinate regulatory documentation, submissions, and tracking activities within regulatory systems.
Collaborate with Quality, Supply, Medical, and other cross-functional teams to ensure regulatory alignment.
Support supply-related regulatory activities, including communication with Health Authorities and GMP-related actions.
Interact with National Health Authorities on regulatory matters.
Manage Unregistered Product Supply in line with local and internal requirements.
Monitor and share regulatory intelligence and relevant competitive insights.
Coordinate activities with local partners and affiliates.
Support implementation of labeling updates (SmPC, PIL, packaging) and maintain compliant product artwork.
Execute lifecycle management activities to maintain compliance of marketing authorizations.
Support regulatory activities across Europe, including the EEA, Switzerland, the UK, and non-EU EEI countries, as required.
Contribute to the development and implementation of regulatory strategies for marketed and development products.
Prepare and review regulatory documentation and support interactions with EMA, RMS, CMS, and other regulatory agencies.
Ensure regulatory milestones are achieved and communicated to stakeholders.
Contribute to process improvements while maintaining regulatory compliance.
Maintain scientific and regulatory knowledge within assigned therapeutic areas.
Adhere to company compliance standards and build effective relationships with regulatory authorities.
Qualifications & Experience
University degree in Life Sciences, preferably Pharmacy or Pharmacology. Regulatory Affairs education is an advantage.
Minimum 2 years of experience in the pharmaceutical industry.
Minimum 1 year of experience supporting European regulatory procedures (MRP, DCP, CP, WS) across multiple countries.
Fluent in written and spoken English; an additional European language is highly desirable.
Proficient with regulatory systems and tools, including Veeva, Ennov, Power BI, and Microsoft Office applications.
Sufficient regulatory expertise to work with limited supervision.
Competencies
Strong written and verbal communication skills.
Excellent organizational, planning, and prioritization abilities.
High attention to detail with the ability to manage multiple deadlines.
Professional and business-oriented approach to work.
Proven ability to collaborate across functions, countries, and organizational levels.
Ability to work independently and within international teams.
Strong project management skills.
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:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
