Regulatory Affairs Manager R&D

Regulatory Affairs Manager

This is a fantastic role with an incredible pharmaceutical company that is well-renowned around the world for its great company culture and DE&I.

About the Company:

• Japan ops est. in the 2000s
• Manufacturing located in 30+ countries; 20+ R&D sites globally
• Therapeutic areas: diabetes, cardiovascular, vaccines, dermatology
• Japan HQ: Tokyo
• WFH available
• Has one of the highest Glassdoor ratings among pharmas
• Ranked in top 5 best healthcare companies to work for by Forbes!

Purpose and Main Responsibilities of the Role:

• Overseeing products either in development or have already been launched in the market but with new indications or dosages.
• Creating a plan for the regulations in developing new drugs, conducting meetings with health authorities, and submitting documents for approval in Japan (J-NDA).
• Drafting the Japanese Common Technical Documents (J-CTD) needed for regulatory submission and organizing the internal review of these documents.
• Managing the preparation of documents, such as the Clinical Trial Notification (CTN), Health Authority meetings (such as PMDA Consultation Meetings), major regulatory submissions (e.g., J-NDA and J-sNDA), and any other documents to respond to Health Authority queries.
• Working collaboratively with stakeholders such as the Non-clinical, Clinical, Medical, and Pharmacovigilance teams.

Required Knowledge and Skills:

- Possess strong leadership skills with a play-to-win attitude, with a focus on strategy and a clear and courageous mindset.

- Able to establish mutual respect through open communication and effective stakeholder management.

- Possess knowledge and experience of regulatory submission and approval processes.

- Experienced in people management, including coaching/mentoring, with a great passion for developing others.

- Respect others with a DE&I (diversity, equity, and inclusion) mindset.

- Language skills: MUST BE Japanese native/N1; and Fluent in English.

Formal Education and/or Experience Requirements:

- Hold a Bachelor's degree in pharmaceuticals or science.

- Have experience in regulatory activities, including interaction with PMDA/MHLW in RA organization.

Desirable But not Essential Knowledge and Skills:

- Knowledge about recent regulatory changes.

- Possess oncology regulatory experience and knowledge.

- Have a network in the Regulatory field/Pharmaceutical industries.

What is Offered:

• Work in one of the world's most prestigious pharma
• Great career development opportunities
• Competitive compensation package
• Work in a global environment
• Telework and Flextime

If you have the experience and skills to take on this great challenge, apply now! Screening has just started and we would welcome talking to you and putting you forward for this exciting opportunity.