Job Description

Project業務

製造所の変更に係るCTD及び申請書の作成(日英)

一変申請後の照会回答作成(日英)

HQとのコミュニケーション(メール、電話会議等)

PMDAとのコミュニケーション

Project: Change of Manufacturing/Packaging site

Preparation of CTD and application forms (Japanese/English)

Preparation of response to inquiries from PMDA (Japanese/English)

Communication with PMDA

The Position

Reporting to the CMC Principal Scientist, Regulatory CMC Japan, the successful candidate will be responsible for assessment of changes for regulatory impact, development of Japan CMC strategy, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for the entire company portfolio of small molecule serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities. He/she will work closely with CMC Product Leads to ensure that company's key CMC projects are successfully prosecuted in Japan.

Appointment to this position will be on local salary and benefits package.

Responsibilities:

The incumbent will be accountable for implementing CMC strategy for Japan for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions, including the following activities:

• For assigned product portfolio, develop robust local (Japan) CMC regulatory strategies for post-approval changes.
• Working collaboratively with Global CMC Regulatory Affairs Product Leads, the incumbent will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the lifecycle.
• Ensure that the Japan CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.
• Support Country RA for creating submitted Appication Form using FD system.
• Act as Regulatory CMC SME in Japan post approval requirements, ensure awareness of local regulatory policy trends and maintain/update the regulatory intelligence repository for Japan, including communicating proactively with Global CMC Product Leads on local registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first time submissions.
• Ensure high quality and timely responses to Regulatory Agency questions and fulfillment of regulatory commitments to Regulatory Agency deadlines.

Required Education, Experience, and Skills:

• The candidate must possess a Bachelor's or Master's Degree in chemistry, pharmacy, biology or a related science, with a minimum of 4 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
• The ideal candidate will have experience in Regulatory Affairs for Japan, with a focus on Regulatory CMC requirements for small molecule products, development, manufacturing and/or quality assurance. Direct Health Authority experience would be an advantage.
• He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
• Must have a proven ability to communicate effectively in both a written and verbal format, in both Japanese and English.
• Ability to influence and work both independently and collaboratively in a team structure.
• Proven ability to work well under pressure.

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 (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: