Job Description
We are seeking a highly skilled Regulatory Strategy Senior Manager to join our team. As a key member of our regulatory department, you will be responsible for developing and implementing optimal regulatory strategies to achieve business targets.
Your primary objective will be to provide and implement regulatory strategy to achieve BMSKK business target by having deep knowledge of up-to-date regulatory affairs and improving the quality of communication with regulatory authorities (PMDA/MHLW).
You will also be responsible for providing mitigation plans for regulatory risks in order to deal with unforeseen situations in the development of new drugs.
The role requires a high level of influence inside and outside the company, as well as globally, to lead discussions with J-HA officers and collaborate with Global Regulatory Strategy TA Directors.
Key responsibilities include:
- Providing appropriate input from a regulatory perspective to the new drug development plan
- Contribute to the development team to ensure that the J-HAs (PMDA, MHLW) accept clinical study plans and the clinical studies are initiated as planned
- Determining whether J-HA interactions are needed and preparing consultation strategies to ensure that the proposed development plan is accepted by the J-HA
- Identifying regulatory risks and notifying all relevant colleagues of these risks and proposing risk minimization or mitigation plans
- Providing advice to ensure that query responses related to CTNs and/or JNDA/sJNDA filing can be submitted within the deadlines
- Collaborating with the GRL regarding the preparation of the regulatory strategy
The successful candidate will have:
- Up-to-date regulatory knowledge required to do the job as described above
- Experience with new drug development work
- Good communication skills, good presentation skills, good strategic thinking ability, good negotiation skills, good leadership skills, good problem-solving ability, good coaching skills both in English and Japanese, and OPA: 6.5
Bristol Myers Squibb is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to diversity and inclusion in the workplace and strive to create an inclusive culture where everyone feels valued and respected.
The salary for this role is estimated to be around $120,000 - $150,000 per year, depending on experience and qualifications.
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