Artwork Specialist, Regulatory Affairs

Job Description

The Position

The candidate will be a part of Regional Regulatory Affairs and affiliate Pharmacovigilance (RAaPV) organization and reporting into the Head of Japan Regulatory Affairs.

Responsible for development and maintenance of local labels, Guide for Patients and artwork (AW) with Global Labeling Working Team, local Development Regulatory, Commercial Teams, Reg CMC, Pharmacovigilance Teams, Manufacturing and Supply Chain Management, Quality, and external service providers with providing local regulations, requirements and regulatory guidance for labeling and AW to responsible functions including global.

Responsible as a point of contact to local Health Authority (PMDA) for maintenance of local labels and Guide for Patients.

Oversee external service providers for package inserts and artwork.

This position needs communication and teamwork skill with responsible functions in local and global.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Responsibilities:

Lead, execute and oversee labeling, Guide for Patients and Artwork.

Specific responsibilities include:

• Develop local labels and Guide for Patients align with Company Core Data Sheet by working with Global Labeling Team, local Development Regulatory, Regulatory CMC, Pharmacovigilance, Regulatory Operations, Manufacturing and Supply Chain Management, and Quality
• Be a point of contact to PMDA for maintenance of local labels and Guide for Patients.
• Closely communicate with responsible functions (see above) to update and manage labels, Guide for Patients and artwork in a timely manner
• Provide and educate local regulations and requirements for labeling and Guide for Patients to responsible functions (see above)

Other activities:

• Negotiate label and package insert with Japanese Health Authorities and Global Labeling Team
• Working in matrix environments including global teams

Required Education, Experience, and Skills:

• Bachelor’s degree and at least 10 years of pharmaceutical industry experiences including at least 3 years of directly related experience, OR
• Master’s degree and 5 years of pharmaceutical industry experiences including 3 years of directly related experience.
• Japanese: native level, English: business level

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)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

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:R523564