Our client is a biopharmaceutical company. They have asked us to assist them in their search for a Director, CMC Regulatory .
Major tasks and responsibilities will include:
Prepares and manages CMC Regulatory content for submissions in all applicable regions, ensuring high quality and timely submissions.
Responsible for submissions including BLAs, MAAs / NDAs - Module 3 and QOS content, supplemental submissions and responses to health authority questions in support of drug product or drug/device combination product development or commercialization.
Supports activities including API development and validation, DP and/or drug/device combination product development, validation and commercialization, Design Control strategy and documentation, and Human Factors validation testing.
Serves as a CMC Regulatory and Combination Product Subject Matter Expert to project teams and/or CMC sub-teams.
Leads regulatory strategy for all activities with Regulatory impact for assigned projects, creates and maintains CMC Regulatory strategy documents.
Ensures completeness and timeliness of CMC submissions, including creation and maintenance of associated tracking systems in concert with Regulatory Operations.
Assures that all procedures are maintained and followed for archiving of appropriate records and regulatory documentation, including agency contact records, regulatory filing records, etc.
Maintains expert knowledge in US and international pharmaceutical and combination product regulations and provides proactive regulatory intelligence, particularly in quickly changing and/or highly competitive areas, in all relevant territories (e.g. US, EU, JP, and ICH).
Develops, contributes to and maintains SOPs with an emphasis on adhering to drug and device regulations and delivering high quality solutions to our patients.
Serves as the key contact for the Company s drug delivery/device partners.
We seek candidates with the following qualifications:
Requires a minimum of a Bachelor of Science degree in life sciences, engineering, or equivalent.
Must have RAC certification; additional regulatory certification is a plus.
Must have eight or more years of experience in the pharmaceutical industry, including drug/device combination product development and commercialization experience.
Experience in oral solid dosage forms is a plus.
Must have experience in developing and submitting successful BLA/NDA submissions with a thorough understanding of the drug development process, FDA regulations and ICH guidelines, with demonstrated expertise in drug/device combination products.
If interested, please email your resume as a Word attachment to us, reference 3683. 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 Scanlon s list of Top 50 Healthcare & Life Sciences Search Firms.
* 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.