Regulatory Affairs Specialist _TAPI

Recruiting Company

Teva API Japan LTD

Who are we?

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.

Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Teva is a wellbeing-oriented organization, and our working atmosphere is pleasant and informal - this is directly reflected in the way we support each other to reach common goals.

Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.

We would like to invite applications for the role of Regulatory Affairs Associate at our Tokyo office to lead and proactively manage all regulatory activities in Japan for assigned projects including compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of changes. You will be part of a highly engaged RA team and you will work closely with PMDA, customers and Teva API manufacturing sites all over the world.

How you'll spend your day

• Management of Japanese Drug Master Files(J-DMFs) as in-country care-taker
  • Registration, life-cycling, Major change or Minor change notification
• New Drug Application of J-DMF
  • Make strategy how to develop J-DMF(including specifications and test method and  manufacturing process)
  • Negotiation with customers
  • Negotiation with the Head office and manufacturing sites
  • Negotiation with CROs(Translation and others)
  • Preparation of J-DMF
  • Submit J-DMF to PMDA
  • Negotiation with PMDA
  • Respond for the queries from PMDA
• Partial change applications or minor change notification
  • Make strategy how to change the documents
  • Negotiation with customers
  • Negotiation with the Head office and manufacturing sites
  • Preparation of the changed documents
  • Submit the documents to PMDA
  • Negotiation with PMDA
  • Respond for the queries from PMDA
• Notify new and updated Japanese Ministerial Ordinances to RA team of Headquarters and manufacturing sites
• Respond for the queries from customers on RA matters

Your experience and qualifications

【Mandatory】

• Experience in the research, manufacturing, regulatory affairs or quality departments of a pharmaceutical company (2 years or more preferred)
• English and Japanese proficiency (reading and writing required, conversational English is preferred)
• Ability and readiness to learn

【Preferred】

• Experience in MF registration
• Pharmacist qualification
• Knowledge of the Pharmaceutical Affairs Law and GMP and experience in working with them
• Experience negotiating with PMDA　
• Experience in customer relations
• Project management experience
• High IT literacy (Microsoft office)

Enjoy a more rewarding choice

Work Place: 7F, 5-1-5, Toranomon, Minato-ku,Tokyo 105-0001 Japan  (Kamiya-cho)

Salary/Annual Income: Determined according to company regulations
Performance bonus: once a year (paid next year)
Trial period: Yes (3 months)
Working hours: 9:00-17:45 (60 minute break; flex system available)
Details of treatment will be announced at the time of interview.

Make a difference with Teva Pharmaceuticals

Apply Online now!

Report to

Ass. Dir, Regulatory Affairs International Markets & TPO

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.