Id: 179859 Location: Wilmington, DE Job Type: Direct Hire
One of our leading clients, a global biopharmaceutical company, focusing on early stage clinical development of oncology and immunology/inflammation is seeking an established Director/Executive Director of Regulatory Affairs CMC; responsible for overseeing both the strategic and operational aspects of Regulatory CMC objectives for all commercial products and R&D projects within the organization, including the preparation, review and evaluation of documents for submission to health care regulatory authorities located in Princeton, NJ office.
These opportunities are direct-hire or contract-to-perm roles. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact Rose Chu, VP in Pharmaceutical & Biotech Services Group at #610-822-1256 for questions.
Company offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential. Please find the qualifications and requirements below. If you feel that this position is one that you are excited about and qualified for, please send over your most recent CV. We are always interested in talking to candidates for current AND future opportunities! ***Please respond directly at firstname.lastname@example.org with your resume attached -WORD document***
Leads the regulatory affairs CMC function with responsibilities and accountability for the oversight and implementation of global regulatory CMC strategy and activities to meet regulatory requirements for all existing pipeline assets and commercial products.
Ensures Regulatory CMC team compliance to global regulatory guidance documents, regulations and laws, as well as internal policies and procedures.
Manages multiple Regulatory CMC team members (direct and/or indirect reports). Recruits, develops and retain highs performing Regulatory CMC employees.
Leads regulatory CMC strategy and submission aspects for both small and large molecule development programs, as assigned.
Leads meetings with internal and external stakeholders/business partners or teams for clinical development programs, in order to communicate regulatory CMC guidance and strategies.
Provides regulatory CMC leadership for due diligence activities and product/company integrations.
Ensures regulatory CMC submissions are of high quality, consistent and complete, and comply with current regulatory standards. Provide critical review of the CMC data packages from other functional team representatives to support clinical trial and marketing applications. Work with CMC functional experts to provide timely responses to CMC regulatory questions from global health authorities.
Liaises with FDA and other health authorities as needed (e.g. telephone contacts, submissions). Lead regulatory CMC related health authority meetings for assigned projects. Prepare summaries of meetings and contacts for inclusion in the regulatory archives.
Manages post-approval global product activities such as, but not limited to, change control, marketing application supplements and variations.
Maintains current knowledge of relevant US and international guidances, laws and regulations, and proposed and final rules which affect CMC pharmaceutical drug development.
Participates in outside professional development meetings and conferences to ensure the latest thinking is applied to CMC strategies.
M.S. or advanced degree (Ph.D. or Pharm.D.) in scientific/life-sciences or related field.
A minimum of 8-12 years' experience in regulatory affairs, with at least 5 years in a leadership role with lead Regulatory CMC responsibilities in a pharmaceutical or biotechnology organization.
Strong knowledge of regulations/guidelines governing development of pharmaceuticals; experience in working with international regulatory agencies.
As a well-funded biotech company, company pays highly competitive salaries and a comprehensive benefits package. Interested individuals are encouraged to contact or submit their CV to the following email address: email@example.com
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We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc- Executive Director Reg. Affairs) in the subject line of your correspondence to ensure review.
Please forward your credentials in Word format through Indeed or call Rose Chu at 610-822-1256 for questions. Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.
Vice President - Pharmaceutical, CRO, Biotech, Medical Device
Global Employment Solutions/Fahrenheit IT
P (610)822-1256 | C (215)-317-2999 | F (610-668-5000) | firstname.lastname@example.org
One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004
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