Executive Director, Japan Regulatory Affairs & Pharmacovigilance

Job Description

The Japan Regulatory Affairs & Pharmacovigilance Head (Japan RAPV Lead) manages RA and PV staff and processes in Japan. He/she is also responsible for ensuring compliance with RA and PV processes and regulations, company policies and procedures, establishing best practices, and representing the company for any safety, regulatory or compliance issues. The Japan RAPV Lead is also responsible for interfacing with HQ, RA Therapeutic Leads, PV, labeling, business process leads, Global Medical Affairs, marketing teams, and other business units to ensure alignment on issues impacting RA and PV activities.

Specifically, as a senior leader, the incumbent will actively provide input to new drug regulatory strategy for Japan and the region starting from early Phase (after PoC) and Life Cycle Management (LCM) activities (i.e.: new indications, line extension, major efficacy variations aligned with regional priorities

The Japan RAPV Lead will be responsible for the following activities for their country and countries within their sub-region (as applicable):

• Define the strategic direction of RA and PV and develop short, medium and long-term action plans to fulfil the strategy
• Ensure the RA and PV teams are aligned to the strategy and are supportive of the company’s global and regional objectives.
• Build leadership and functional capability within the RA and PV teams to keep pace with the changing science and regulatory environment, as well as managing departmental resources in line with changes in portfolio volume and priorities.
• Be accountable for the planning and execution of RA and PV strategies for medicinal products and medical devices
• Be responsible for delivery of cross-divisional projects, by leading the RA and PV teams to collaborate with other functions to ensure that global and regional objectives are met.
• Be recognized as a subject matter expert and driver of innovation in RA and PV processes, pathways, and compliance and be considered a thought leader both externally and internally, increasing company’s credibility in the pharmaceutical sector.
• Be accountable for maintaining products on the market through timely delivery of RA and PV commitments, as well as achieving approval for new products.
• Deliver regulatory success as a key revenue driver, both for existing and new revenue streams.
• Partner with Global Clinical, MAOR and Commercial functions within the cluster to ensure the company’s compliance with registration and pharmacovigilance requirements as well as legal requirements administered by the country Health Authorities, supporting the country’s continuous growth.
  

The position reports to the APJ RAPV Lead and is a member of regional leadership team and other relevant RA and PV teams. As requested, the incumbent may undertake additional activities. Travel within the region and globally may be required.

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 staffingaadar@organon.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)

Employee Status:

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:

Requisition ID:R520682