Regulatory Affairs Senior Director

Hobson Prior is working alongside a pharmaceutical company seeking a Regulatory Affairs Senior Director to permanently join their team.

Please note that to be considered for this role you must have the right to work in this location.

Summary of Job (brief description)

We are seeking a highly motivated, enthusiastic, and experienced regulatory professional to join as the Director / Senior Director, Regulatory Affairs. This role will be responsible for providing strategic regulatory guidance to ensure compliance with all applicable regulations and guidelines for marketing authorization submissions outside the US. This role will collaborate closely with cross-functional teams to support product launches, lifecycle management, and other development and commercial activities. This role will be based out of our office in Redwood City, CA to foster a strong team and collaborative work dynamic.

Responsibilities

• Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects consistent with corporate goals and strategies.
• In close collaboration with local partners and/or CROs, proactively lead the preparation, submission, and maintenance of global regulatory dossiers while ensuring consistency of content and messaging across applications.
• Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
• Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
• Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities
• Maintains knowledge of regulatory requirements up to date and communicates changes in regulatory information withing the regulatory department as well as to other departments.

Qualifications

• A degree in a life science or closely related discipline with a higher degree preferred (e.g., MSc, MPH, PhD, PharmD.).
• A minimum of 15 years direct pharmaceutical regulatory affairs, including 5 years of International Regulatory experience is required.
• Experience in a small company and hands-on marketing application experience from preparation through submission and approval in a non-oncology, rare disease indication is strongly preferred in regions including, but not limited to EU, APAC, and LATAM.
• Proven ability to manage multiple complex projects, with the flexibility and adaptability to re-prioritize workload.
• Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates.
• Must be a hands-on team player who thrives in a fast-paced, team environment.
• Excellent verbal, written, negotiation and interpersonal skills are required. Must be articulate and able to communicate effectively both orally and in writing with employees at all levels of the organization and external audiences.

For more information, please contact Raymond Pankhurst.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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