Global Regulatory Affairs Senior Manager
Reporting to the Global Head of Regulatory Affairs, you will be actively involved in supporting the development of innovative new medicines, including small molecules, biologics and radiopharmaceuticals. You will contribute to and/or be responsible for the implementation of regulatory strategies spanning from First-in-human studies up to registration, including support to out-licensing activities. As part of these activities you be involved in defining development paths that maximize the value of our compounds and enable early access to patients with high unmet medical need. You will also be responsible for the compliance with applicable regulations.
- Support the Regulatory Affairs core-team representative in the implementation of Regulatory Affairs strategy for assigned projects. When required, be the representative of Regulatory Affairs in project core-teams
- Represent Regulatory Affairs in various cross-functional sub-teams, such as Clinical Study Teams.
- Lead and coordinate the preparation of several submissions, such as: INDs/CTAs, Briefing Documents to support meetings with Health Authorities in several jurisdictions, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc.
- Work closely with functional experts to coordinate their contributions to regulatory documents.
- Manage the regulatory CROs for coordination and preparation of submissions.
- Review and approve documents of regulatory relevance such as Clinical Study Protocols, Clinical Study Reports, DSURs, etc.
- Maintain knowledge of the global competitive and regulatory landscapes.
- Bachelor’s degree in Health/life-sciences; a high degree is preferred.
- 5-8 years of experience in regulatory affairs within the pharmaceutical industry. Global (FDA and EMA) experience desired.
- Demonstrated regulatory knowledge and experience in early phases (Phases I-III) of drug development. Experience in oncology is a plus.
- Necessary skills: Independent, result driven, team-oriented, agile individual with the ability to influence outcomes.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing activities simultaneously.
- Must be able to innovate, analyze and solve critical problems with minimal supervision and attention to detail.
- Excellent written and communication skills in English.