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Regulatory Affairs Director - Germany / Remote
142145
Posted:
26th
March 2024
- 120000 EUR - 140000 EUR
- , Germany
- Permanent
Director Regulatory Affairs (hands-on) - Oncology - Germany / Remote
Summary
Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.
Responsibilities
Working in partnership with the Head for International Regulatory Affairs:
Qualifications:
Summary
Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.
Responsibilities
Working in partnership with the Head for International Regulatory Affairs:
- Provide strategic advice to project teams with respect to Europe and Israel
- Assist and manage MAA submissions and NDA as necessary
- Develop briefing packages for meetings with global health authorities (country specific competent authorities and EMA as necessary
- Develop regulatory timelines
- Lead the compilation of key regulatory documents and other assigned tasks within the established timelines. Ensure appropriate scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs.
- Identify and assess regulatory risks for assigned projects or
- Serve as point of contact for functional areas and as a member of clinical project team
- Define regulatory expectations for program teams
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
- Develop strategies and drafts and/or review responses and other documents intended for submission to global health authorities and Ethic Committees
- Manage and oversee vendor(s)
- Ensure regulatory compliance with pre- and post-approval filing and reporting requirements
- Prepare and deliver effective presentations for external and internal
- Primary contact for regulatory agencies relevant to assigned projects or programs, as
- Prepare and participate and contribute in Health Authority
- Up to 20% international travel
Qualifications:
- Minimum M.S. degree in life/health/technical sciences required
- Minimum 6 years regulatory experience with at least 5 years of experience within the biotech or pharmaceutical industry; oncology experience required. Experience with submitting CTA/MAA.
- Working knowledge of ICH- GXP, EMA requirements
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group
- Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports
- Demonstrated written and verbal communication
- Strong interpersonal skills and the ability to deal effectively with a variety of personality types
- Experience working in a multi-cultural environment
- Experience in working in matrix environment.
- Experience in interfacing with relevant regulatory
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or
- Knowledge and understanding of applicable Computer literate
Alexey Badulin
Division Manager