Position Title
Deputy General Manager (DGM) Regulatory Strategy (Düsseldorf)
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.
We are currently seeking an experienced and professional Regulatory Affairs deputy general manager to join our team. As the DGM Regulatory Strategy, you would be reporting directly to the General Manager head of regulatory, medical & scientific affairs. In this role, 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.
Scope & Responsibilities
- provide MTP Group senior management with clear strategic clinical development regulatory advice and services
- Key part of this role is to provide EU & MENA strategy to the Global Development teams for the EU through the GRA PT
- 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 and for ensuring the strategy is designed to deliver an earliest possible approval with a viable label, taking into account the needs of the business and the patients
Knowledge & Skills
For assigned development & marketed compounds accountable for planning, preparation, review and submission of high-quality applications to regulatory authorities (e.g. EMA) leading to approval in a timely manner. These submission may include (but not restricted to):
- Marketing authorization applications
- Clinical trial (& Ethical Committee) applications and amendments
- 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
- Orhpan Drug Designation request & meetings with COMP
- Answers to regulatory questions working with Rapid Response Teams (RRT)
- Provides the consolidated EU Development and submission strategy to the Global Regulatory Strategy Plan (GRSP)
- Maintains regulatory intelligence and awareness of competitors’ activities and shares potential impact these regulations/activities may have on the product development program/life cycle
- Drives and leads all interactions with the European Medicines Agency other competent authorities and relevant committees incl. CMDh
- 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
- Responsibly represents GRA on internal and Mitsubishi Tanabe Pharma on external events (e. g. conferences, working groups, industry associations etc.)
- 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 ensuring staff are adequately trained in SOPs
Requirements
- Life sciences degree
- 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 on global scale
- Extensive broad regulatory experience in pre and post marketing authorization phases.
- 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.
- Extensive knowledge of European and US regulatory requirements.
- Knowledge of requirements in Japan and emerging markets desirable
- Knowledge and experience on medical devices and interactions with NB of Europe
- Experience of representing the sponsor company at external meetings such as meetings with regulatory bodies and health authorities (e.g. FDA/EMA/NB and others)
- Previous line management experience beneficial
- Excellent attention to detail, communication and interpersonal skills.
- Fluent verbal and written communication skills in English and German.
- Knowledge in standard computing tools (e.g. Office software)
- High level of reliability and demonstrated teamwork.
- Ability to work independently and with high accuracy
Location/Salary&Benefits
This position is located in our Düsseldorf office with the option of hybrid model (2-3 days/week in office)
Competitive salary and benefits package
Contact:
hrmtpd@joka-hr.de
a.khan@mt-pharma-de.com
www.mt-pharma-de.com