Job Description

The Position

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

Responsibilities

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Work and execute tasks with minimal support from line managers.

• Be accountable for implementing regional CMC strategy for Japan market for new product submissions and post-approval CMC supplements with a focus on achieving right-first-time submissions.

• For assigned product portfolio, develop robust Japan CMC regulatory strategies for new marketing applications, Scientific Advice and post-approval changes.

• Working collaboratively with Global CMC Regulatory Affairs Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the products 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.

• Boost Country RA affiliate interactions with their local Regulatory Agencies to facilitate Scientific Advice and the prompt review and approval of submissions (as CMC content subject matter expert). 

• 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 promote right first-time submissions.

• Ensure high quality and timely responses to Regulatory Agency questions in Japan and fulfilment of regulatory commitments to Regulatory Agency deadlines.

• Sponsor product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.

• Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.

• Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.

Required Education, Experience and Skills

In order to excel in this role, you will more than likely have:

• Possess a Bachelors or Master's Degree in chemistry, pharmacy, biology or a related science.

• Minimum of 10 years' experience in Japan CMC Regulatory Affairs with a focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing and/or quality assurance.

• Experience with investigational new products applications would be an advantage.

• Direct Health Authority experience would be an advantage.

• Demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.

• Excellent written and verbal communication skills; the ideal candidate will be fluent in both Japanese and English.

• Ability to influence and work both freely 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. 

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: