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Regulatory Affairs Director
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Regulatory Affairs Director
vor 2 Wochen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout Daiichi Sankyo Europe GmbHWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer.The RoleWe are seeking...
Director of Regulatory Affairs
vor 4 Monaten
**Reference Number**: JO-2304-514347
Director of Regulatory Affairs - (EU Relocation)
**Rate**: Negotiable
**Job Type**: Permanent
**Location**: Munich
Director, Regulatory Affairs - Infectious Diseases
Munich, Germany /Europe - Relocation Package Provided.
**Salary**: Attractive salary plus benefits package (stock options, car allowance, bonus )
Working for one of the industry’s most innovative biotechnology companies, this is a fantastic opportunity to provide expert regulatory knowledge to an early-stage infectious disease development program, with a focus on the EU market.
This role will be responsible for leading the EU Regulatory Team across multiple geographies, providing support, mentorship, and advice in a challenging regulatory environment. You will have a sound understanding of the infectious disease space, be able to devise strategies in line with business requirements globally, and be able to influence at a high level internally and externally.
**Responsibilities**:
- Lead, manage and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.
- Build the representation of EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
- Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
- As needed, support activity with Business Partners to ensure the EU regulatory strategy meets business objective.
- Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
- Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
- Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.
Job Requirements
- Advanced degree in a scientific discipline.
- 10+ years regulatory experience with a focus on supporting products through clinical development.
- Experience of managing and developing staff members desirable.
- Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
- Experience of providing EU regulatory strategy for infectious diseases is desirable.
- Experience of monoclonal antibodies is desirable.
- Experience of bringing a product through EU approval is a distinct advantage.
- Ability to negotiate and concisely express clear positions to stakeholders at all levels.
- Experience of directly working with national regulatory agencies and leading agency meetings face to face.
- Excellent written and verbal communication skills.
This is a great opportunity for a science-minded individual to work at the heart of innovation on a developing infectious disease portfolio. You will take lead and work with senior board members across the globe to define regulatory / business strategy.
