Regulatory Affairs VP
Hobson Prior is working alongside a pharmaceutical company seeking a Vice President of Regulatory Affairs to join our client's team in Framingham, MA. This role requires you to be in office 3 days per week.
Please note that to be considered for this role you must have the right to work in this location.
About the role:
This company seeks a dynamic and experienced Vice President, Regulatory Affairs to expand, enhance and manage all aspects of our global Regulatory Affairs function. Reporting to the Sr. VP, Regulatory Affairs & Quality Assurance, you will be an integral member of the Senior Leadership Team accountable for providing leadership and expert regulatory input to the strategic direction and long-term success of the business.Key responsibilities include ensuring the submission of regulatory applications are in line with corporate goals while establishing regulatory guidelines that always meet compliance requirements.
Responsibilities:
- Ensure regulatory objectives are met to support the Corporate Goals
- Guide and direct the regulatory team to ensure appropriate regulatory strategy and regulatory requirements are met for all early development/late development/commercial products
- Guide, mentor and direct the regulatory team to ensure a highly functioning team, resourced to enable Corporate Goals to be met
- Management of the annual budget for Regulatory Affairs
- Provide input/expert review of regulatory submissions as required (e.g. CTA/IND, Orphan Drug Designations/Fast Track/Breakthrough Designations NDA/MAAs)
- Ensure maintenance of good rapport/communication with all Competent Authorities
- Review and approve regulatory SOPs as needed and ensure regulatory affairs function is compliant with all aspects of the QMS
- Support RoW functions in regulatory due diligence activities
- Maintain an up-to-date knowledge of all applicable FDA/EU/other international regulations and laws and undertake training and/or information sharing with colleagues to ensure that the business implements appropriate processes to maintain compliance
Qualifications:
- Bachelor's degree required. Advanced degree preferred
- 20+ years' experience in global regulatory affairs, including hands on preparing/writing/submitting of at least one NDA or MAA and management of post-approval regulatory activities
- Experience providing regulatory support for early phase development (bench to Phase II) is preferred
- A proven, driven leader able to guide, direct and challenge the status quo across International & functional boundaries
- Excellent communicator and problem solver with the ability to influence at the Executive and Board level and experience working with FDA Divisional Heads & Regulatory Project Managers as well as OUS regulatory agencies
- Ability to thrive under pressure to deliver on complex projects on exacting timelines
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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