Job summary
Japan Regulatory Leads (JRLs) formulate and conduct high quality development regulatory strategies in order to obtain simultaneous worldwide approval in Japan or ahead of the world and to optimize the Benefit/Risk balance based on a label that maximizes the medical value of products. JRLs have responsibility for the execution of the strategy by leading the negotiations with health authorities and collaborating with the Japan Medicine Team (JMT) and related departments. Regulatory Expert Managers, support the Japan Regulatory Strategy Group Lead (RSGL) in supporting, coaching, and developing colleagues to assure that the aforementioned objectives are achieved.
Job responsibilities
JRL executes the following roles and responsibilities:
1. Think outside the box when formulating a high quality development regulatory strategy, by analyzing/utilizing the profiles of products under development, and healthcare and regulatory environment, in order to obtain simultaneous worldwide approval in Japan or ahead of the world and to optimize the Benefit/Risk balance based on a label that maximizes the medical value of products.
2. Perform the following activities in accordance with the regulatory strategy.
Take the leading role in responding to and negotiating with the regulatory authorities. Formulate “External Environment” strategies for products under development.3. Lead the preparation of PMDA consultation strategy and briefing documents.
4. Lead the Rapid Response Team to prepare responses to PMDA queries, and obtain the company’s approval for them.
5. Lead the preparation of JNDA submission documents (CTD) in accordance with the regulatory strategy.
6. Lead the team in the discussions and information exchange with Pfizer global so that the Japanese Regulatory strategy is consistent with the global regulatory strategy.
7. Cooperate with relevant departments to establish a high quality strategy for Medical and Marketing.
8. Provide optimal input to Risk Management Plan (RMP) based on the characteristic of the drug and development strategy.
Qualifications/ Skills
Strategic, outside-the-box thinking/planning ability.
Receptivity for the ideas/opinions of other members, and open attitude to incorporate them when formulating a strategy.
Leadership and organizational ability to take the initiative in executing regulatory work, and to coordinate with Development Japan, Marketing, and Medical.
Comprehension skills to accurately understand the thought/needs of the regulatory authorities in each therapeutic area.
Interpersonal skills to strengthen a relationship of trust with the regulatory authorities
Communication skills to accurately explain regulatory information to Pfizer internal stake holders so that they understand correctly.
English communication skills (ability to construct a logical argument, read, write, and speak in English).
Knowledge/experience in innovative drug development and regulatory strategy.
Scientific comprehension of science and medical information to execute the above role and responsibility.
Ability to contribute to the on-the-job training of RSG colleagues by supporting, coaching, and skill development.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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