Director, Regulatory Affairs

工作内容

Position Summary

As Director, Regulatory Affairs, you drive optimal EU regulatory strategies for assigned products during product development and manage EU regulatory objectives (nonclinical, clinical, CMC) in alignment with department and corporate goals. You work closely with cross functional project teams to support product development, global clinical trials and marketing approvals, while ensuring that EU regulatory strategies are implemented and EU requirements for the assigned projects are achieved. You possess thorough knowledge of European rules, regulations, and guidance governing drugs, biologics and ATMPs (e.g. gene therapy) in all phases of development. Strong communication and management skills are required. In this position, you report to the Vice President, Head of Regulatory Affairs Europe.

This role can be based in Basel, Switzerland. We will also consider remote candidates.

Your Responsibilities Include

Define, develop and lead regulatory strategies to maximize the likelihood of regulatory success in Europe and to support the global program development plan
Provide proactively strategic and tactical guidance and regulatory support to cross functional teams and corporate partners to ensure timely and efficient conduct of development programs
Plan/oversee/prepare key European regulatory documents (briefing documents) to support central and national advice, Orphan Drug Designations, Pediatric Investigation Plans Marketing Authorisation Applications while ensuring consistency with EU regulatory requirements and the global regulatory program strategy
Proactively identify program issues and support to implement appropriate regulatory strategies to mitigate risks
Function as primary liaison with regulatory authorities, affiliates and consultants
Strategically plan, prepare, and execute meetings and teleconferences with regulatory authorities
Oversee the planning and execution of high quality submissions and responses to regulatory authorities, including meeting materials, amendments, and annual reports
Provide oversight and guidance to clinical study teams as applicable to ensure EU regulatory requirements are met and that the clinical trial meets EU program development goals and timelines
Provide EU regulatory expertise to the global regulatory team to develop and implement the regulatory program strategy and submission plan
Review and approve applicable promotional/disease awareness materials
Ensure accurate retention of all regulatory submission and contacts with health authorities in the archival system
Maintain knowledge of and monitor changes in current European rules, regulations, and guidances governing drugs, biologics and ATMPs in all phases of development, as well as knowledge of therapeutic area(s)
Lead or contribute as required to the development of SOPs to support regional and local processes

What You Bring To The Role

BA/BS degree in life sciences or experience in drug development that allows for sufficient knowledge in this area. Advanced degree preferred
Strong scientific background with at least eight (8) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries
Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies
Work independently and in a team environment, with strong leadership, negotiation and influencing ability
Thorough understanding of European drug development regulations and guidelines
Proven ability to successfully manage major submissions and critical projects to deadlines
Proven ability to successfully interact with regulatory authorities
Experience with development of drugs/biologics/ATMPs for rare diseases is preferred Excellent attention to detail with solid coordinating, task planning and time management skills
Outstanding verbal, written and interpersonal communication skills
Proficient use of Office 365, cloud-based and virtual collaboration tools expected (MS Office tools, EDMS, Internet resources, Zoom, OneDrive)
Languages: fluent English, other European languages are a plus
Travel requirements approx. 10% (more if located outside of Switzerland)