Specialist, Regulatory Affairs
An amazing opportunity has arisen for a Regulatory Affairs Specialist. Under supervision of the Associate Director, Regulatory Affairs, you will join a small team within Pharmacovigilance/Regulatory Affairs at an exciting time in a company set up. Be part of something new ...
*Candidates should be able to come into the Dublin office once per week*
Bring energy, knowledge, innovation and leadership to carry out the following:
- For assigned products and under supervision of the Senior Specialist, Regulatory Affairs ensure timely preparation, submission and appropriate follow-up of new Marketing Authorization (MA) applications to the local authorities and – as applicable – to the European Medicines Agency (EMA).
- Ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, PSURs and supplemental marketing authorizations.
- Ensure timely, accurate and compliant labeling and artwork preparation for assigned products.
- Stay updated on company filings, relevant EU and local regulations and guidelines. Design and implement regulatory ad-hoc local action plans, as necessary.
- For assigned products and tasks, work alongside the business to promote business initiatives in sub region.
- Collect relevant publicly available regulatory information (regulatory intelligence) and keep relevant persons appropriately informed.
- Maintain a positive relationship with internal and external regulatory contacts. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
Major activities include, but are not limited to:
New MA applications for assigned products:
- Perform timely and correct submission and approval of assigned new Marketing Authorization applications in close teamwork with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments as well as with local regulatory authorities as appropriate, regarding procedure type.
- Track process and manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
Maintenance of licenses for assigned products:
- Ensure that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the established timeframes and communicates approvals to stakeholders through the correct processes.
- For major indications, design and implement local action plans as required.
- For assigned products, ensure timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to company and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
- Ensure that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
- Ensure the correct and proper utilization of artwork management systems to generate mock-up artwork and to implement revisions to artwork.
- Ensure efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
- Ensure that files and archives related to Regulatory are kept updated and complete.
- Participate in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
- Participate in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
Labeling and artwork:
- Ensure high quality QRD check of Summary of Product Characteristics and Patient Package Leaflets.
- Ensure availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.
- Ensure adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
- Provide regulatory guidance to the license companies/joint venture/co-marketing partners as appropriate.
- Secure timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
- Take part in subsidiary product and launch teams to provide regulatory input and advice.
- Keep abreast of local and international laws.
- Shape the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders.
Required Education, Experience, and Skills
- Hold a degree in pharmacy or other life science with a minimum of 2 years experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies.
- Be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products. Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
- Possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. Must be able to work both alone and as part of a team.
- Demonstrate proficiency in English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet.
- Sound appreciation of the interactions and relationships of the dept with other groups internally is expected.
- Have a client-oriented approach and work according to the company leadership vision.
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.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at email@example.com.
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)
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites10%
Flexible Work Arrangements:Flex Time
Valid Driving License:No
Number of Openings:1