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Job description

Senior Director, Regulatory Affairs (Regional Lead)

BioTalent is proud to be working with a clinical stage immunology company to support their search for a Senior Director Regulatory Affairs EU.

Location
This role can be based in either Switzerland or the Netherlands. The client offers a flexible, work-environment and can support home based, remote options in either location.

The role:
As a Regulatory Affairs Regional Lead, you will be responsible for regulatory drug development activities including development and successful execution of regulatory strategies, plans and processes within the EU and UK region.

The successful applicant will be responsible for providing strategic, regulatory leadership in the development, commercialization, and management of assigned projects. Therefore, the role requires knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies.

Responsibilities:

Develop and implement the EU and UK regional regulatory strategy, aligned with global regulatory strategy to deliver rapid approval.
Own the development of the EU and UK regulatory strategy for assigned product(s), and the planning and construction of the global dossier and core prescribing information
Lead cross-functional teams in major EU and UK regulatory submissions, health authority interactions, label discussions, and securing approvals
Deliver regulatory achievements for assigned project(s), including the assessment of risks and mitigations, emerging data, and the probability of regulatory success
Ensure effective teamwork across Regulatory Affairs and functional areas, enabling rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support

Your profile:

PhD or PharmD preferred, minimal MSc- degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
15+ years’ experience in drug development, 10+ years in regulatory
Experience as direct contact with Major Health Authority
Previous experience in developing materials, attending, and supporting team preparation Major Health Authority interactions
Experience in EU/EMA/UK submission portal
Detailed knowledge of regulatory drug development including product approval/launch
Ability to think strategically and critically evaluate risks to regulatory activities
A proven track record in leading submissions, interactions with regulatory authorities, approvals and complex programs across the responsibilities of the specific role
Previous experience in therapies for rare diseases and small molecules
Ability to work strategically within a business-critical and high-profile development program
Critical thinking on current regulatory science questions and a good understanding of the corresponding scientific and clinical components
Excellent verbal and written communication and presentation skills (English). Fluency in writing regulatory documents such as IMPDs, INDs, NDAs, MAAs.
Strong team player and ability to work across functions (matrix regulatory team)
Comfortable in a small company environment that is fast paced, challenging and where all leaders must take on a hands-on approach to get results
Ability to multi-task and manage workload independently
Excited and driven by science and the vision to improve disease management and patient care.