Regulatory Strategy – Deputy General Manager (Pharma) (1744)

Regulatory Strategy – Deputy General Manager (Pharma)

This position is located in our Düsseldorf office with the option of hybrid model (2-3 days/week in office).

Fluency in German and English is required.

About Us

At Mitsubishi Tanabe Pharma, we maintain the highest ethical standards, place top priority on fairness and integrity in all activities, and act in accordance with relevant guidelines. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter

Future to people around the world.

Role Summary

As the DGM Regulatory Strategy, you would be reporting directly to the General Manager Head of Regulatory, Medical & Scientific Affairs. You will play a central role in driving a proactive RA strategy for the assigned compounds, from our early & late-stage development molecules and supporting the leadership team to drive business objectives. You will deliver to Group senior management, clear strategic clinical development regulatory advice and services, and provide EU & MENA strategy to the Global Development teams for the EU through the GRA PT. You will be the recognized regulatory product/project expert for assigned Brands/development compounds and as such accountable for the development and implementation of the regional and/or global regulatory strategy.

Responsibilities

For assigned development & marketed compounds, you will be accountable for planning, reparation, review and submission of high-quality applications to regulatory authorities (e.g. EMA) leading to approval in a timely manner. These submissions may include (but not restricted to):

• Marketing authorization applications
• Clinical trial (& Ethical Committee) applications and amendments and end of study notifications, clinical study report & safety summaries
• Scientific advice meeting briefing packages
• EMA Scientific advice/attendance at FDA meetings (to support at the request of MTPA RA) & protocol assistance requests.
• Pediatric Plans (PIP) & meetings with PDCO
• Orphan Drug Designation request & meetings with COMP
• Providing the consolidated EU Development and submission strategy to the Global Regulatory Strategy Plan (GRSP)
• Maintaining regulatory intelligence and awareness of competitors’ activities and related impact
• Driving and leading all interactions with the European Medicines Agency other competent authorities and relevant committees.
• In case of drug device combination medicinal products dealing with Notified Bodies and having the knowledge and experience of EU MDR
• Technical file submissions, CE marking to EU notified bodies – having basic knowledge of medical devices and understanding of EU MDR in terms of supporting experience in dealing with various notified bodies.
• Representing GRA on internal and Mitsubishi Tanabe Pharma on external events
• Ensure compliance with relevant Mitsubishi Tanabe Pharma internal policies as well as external regulatory requirements through updating and creating of new SOPs as required and related trainings.

Requirements

• Degree in Life sciences (or equivalent) with a significant track record and experience in regulatory affairs, in the pharmaceutical or healthcare industry.
• Significant exposure in RA development both early and late-stage development.
• Extensive regulatory experience in clinical development from Phase I through
• to MAA submission and approval including working with NDA/BLAs, MRP/DCP/CP, PIPs, CTAs and MAAs.
• Knowledge and experience on medical devices and interactions with NB of Europe, and broad regulatory experience in pre and post marketing authorization
• Extensive knowledge of European and US regulatory requirements (Japan and emerging markets desirable)
• Experience of representing the sponsor company at external meetings such as meetings with regulatory bodies and health authorities.

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