Head of Regulatory Affairs
Our client is a biotherapeutics company. They have asked us to assist them in a search for a Head of Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads the development and implementation of clinical, pre-clinical and CMC regulatory strategy for projects in all stages of development.
- Provides regulatory leadership and guidance to project teams.
- Provides leadership for the development of regulatory submissions.
- Manages execution of regulatory submissions, including working with vendors.
- Ensures regulatory compliance with pre- and post-approval filing and reporting requirements.
- Develops response strategies and submissions to regulators.
- Develops briefing packages for meetings with FDA and other global health authorities.
- Ensures clinical, nonclinical and CMC programs are designed and implemented to meet regulatory requirements.
- Manages or delegates the management of the completion of documents and other assigned tasks within established timelines and with high quality.
- Develops strategies and drafts and/or reviews responses and other documents intended for submission to FDA and other global health authorities.
- Provides regulatory leadership for promotional material review.
- Functions as liaison with FDA and other regulatory authorities.
- Is responsible for coordinating all aspects of regulatory submissions for all projects or programs.
- Leads preparation and execution of meetings with regulatory authorities.
- Identifies and assesses regulatory risks for all projects or programs.
- Prepares and delivers effective presentations for external and internal audiences.
- Manages direct reports and grows department.
- A Bachelor’s degree in in life/health/technical sciences is required.
- At least eight years of regulatory experience within the biotech or pharmaceutical industry is preferred.
- Experience in the pain therapeutic area is ideal, but not required.
- Device experience preferred.
- Must have experience leading interactions with regulatory authorities in US and ex-US.
- Successful NDA experience is highly preferred.
- Both CMC and clinical regulatory experience is preferred.
- The ability to work both independently and within project teams, committees, etc. to attain group goals is required.
- Must demonstrate excellent communication skills.
- Requires strong organizational skills, including the ability to prioritize workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel are required.
- Experience in interfacing with relevant regulatory authorities is required.
- Must have experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Requires the knowledge and understanding of applicable regulations.
- Must have experience in interpretation of regulations, guidelines, policy statements, etc.
- Must be computer literate.
- Ideally, this role will spend 3-4 days in the office, but some flexibility is possible.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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