Our client is a clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Director / Senior Director Regulatory Affairs.
Major tasks and responsibilities will include:
Develops and leads the regulatory affairs strategy across all assets in the pipeline.
Plays a key role in developing and implementing corporate regulatory strategy to ensure competitive advantage and regulatory compliance.
Ensures adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements.
Develops and implements a registration path for early clinical development stage programs.
Develops content and format for regulatory submissions, such as INDs, MAAs, BLAs, clinical protocols, and related supplements/amendments.
Leads communications with external regulatory consultants on a project basis.
Advises internal personnel regarding the development and implementation of regulatory strategy through non-clinical, clinical, manufacturing, and other processes.
Identifies potential regulatory concerns.
Develops internal processes for regulatory review of various documents such as clinical protocols, manufacturing changes, etc.
Oversees preparation, submission, application, and routine reports, including preparation of amendments and supplements, as required.
Sustains excellent relationships and negotiates directly with regulatory agency personnel. Responds to requests for additional data, and organizes/manages participation in meetings.
Implements and reviews current policies and practices issued by Federal and international regulatory agencies. Stays abreast with changes to regulations and guidelines.
We seek candidates with the following qualifications:
Bachelors degree required. Masters degree or PhD highly preferred.
Requires a minimum of 8 years of biotechnology/pharmaceutical industry experience.
Must have significant clinical regulatory experience.
Experience with oncology products preferred.
Requires experience with programs leading to accelerated approval and leading communications with the FDA with successful completion of BLA and MAA application(s).
Must have working knowledge of eCTD submissions and supportive technologies.
If interested, please email your resume as a Word attachment to us, reference 3795 AND 3794. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlons list of Top 50 Healthcare & Life Sciences Search Firms.
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.