Director of Regulatory Affairs

A fantastic new permanent position has arisen for a Director of Regulatory Affairs to join a biopharmaceutical organisation who are focused on the development and commercialisation of ground-breaking therapies for diseases within the eye. This role will be 3 days based in the office in Bedford (US) and 2 days working remotely.

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

Job Responsibilities:

• Accountable for assisting in the preparation and compilation of domestic and international product submissions, with guidance. This may include, but is not limited to: PMAs, 510ks, international dossiers and/or CE technical files; INDs, NDAs, MAAs, NDS and global CTAs. This also includes all lifecycle maintenance filings necessary to support these applications (e.g. CMC supplements/notifications, 2253 submissions, annual reports, efficacy supplements and safety reporting).
• To assist with the preparation and compilation of regulatory information requested during regulatory inspections.
• You are accountable for agency establishment registrations and device/drug listings.
• Support domestic and international field corrective actions and adverse event reporting, when necessary.
• Assist in response to Health Authority inquiries.
• Assist in the development and submission of any necessary global CTAs, maintain global CTAs throughout development lifecycle for pharmaceutical products.
• Review product and process documentation for assigned projects to ensure compliance with regulatory dossiers.
• Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
• To coordinate development and submission of annual Developmental Safety Update Reports.
• Provide regulatory research information as requested.
• Perform other regulatory affairs duties when requested.
• Any other assigned duties.

Key Skills:

• You are a self-starter and have the ability to work self-sufficiently to drive projects in accordance with established company objectives.
• A robust understanding of global regulatory affairs regulations and expectations.
• Strong team member with ability to identify and drive process improvements.
• Excellent verbal and written communications skills.
• Strong organisational skills and attention to detail.

Requirements:

• A minimum of 10+ years' experience in regulatory affairs in the pharmaceutical industry.
• 3-5 years of experience in managerial role.
• Demonstrated experience in preparing and gaining acceptance for all types of US based submissions, PMA submission experience and global investigational and commercial submission experience preferred.
• Proven track record of increasing responsibilities with skills in leadership and management.
• Proven track record of increasing responsibilities with skills in leadership and management.

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.