Associate Director, Regulatory Affairs - Fairway Consulting Group
Fairway Consulting Group
125 Janelle Blvd
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Our client is a global biopharmaceutical company. We have been asked to identify candidates for their Associate Director Regulatory Affairs .
Major tasks and responsibilities will include:
Represents Regulatory Affairs function on the Global Project Team and Regulatory Team on assigned projects.
Assists in oversight of regulatory strategy for assigned projects in the Regulatory Affairs Department.
Provides the development and implementation of regulatory strategies for development and approval of new drugs/biologics in the US.
Develops coordinated regulatory strategy with global colleagues.
Contributes to strengthening and developing the Regulatory Affairs function and role in global development.
Provides US specific regulatory input for development projects destined for the US market as assigned.
Offers strategic and operational regulatory support to CMC, Nonclinical, Clinical, Submissions, and other groups as necessary.
Oversees the activities for the planning, implementation, and maintenance of regulatory operational management.
Interacts with project team members in assessing and reviewing data for regulatory submissions.
Serves as liaison with regulatory agencies as necessary in support of development projects in North America, and build working relationships with agency personnel.
Liaise with regulatory consultants, CROs, and other vendors when required.
Provides US regulatory intelligence, including interpretations of applicable or newly issued regulations and guidelines, and business events that may affect the competitive landscape of projects in development.
Keeps project team abreast of regulatory decisions, issues, potential problems and new regulations.
Supports expansion of the company s knowledge base of regulations and guidelines governing the research, development, and marketing of drugs and biologics.
Provides educational training to regulatory team members in the improvement of drug development processes.
Assists in planning and execution of departmental training program.
Serves as Global Regulatory Leader if assigned.
Develops, implements, and executes all company regulatory submissions for assigned US projects in support of multiple IND and DMF dossiers with health authorities.
Creates, implements, and oversees document management processes for all documents, in support of all US IND and DMF activities.
Leads the transition to global electronic submissions.
Assists in management of SOPs for all Drug Development functions, ensuring compliance and continuity amongst impacted departments.
Prepares SOPs for Regulatory Affairs activities and responsibilities, and contributes to preparation of other department SOPs, as needed.
Reports to the Senior Director of Regulatory Affairs.
We seek candidates with the following qualifications:
Bachelor s degree in Life Sciences or Pharmaceuticals required. Advanced degree (PhD, PharmD, or Masters) in a clinical, health-related field or life sciences field highly preferred.
Must have a minimum of 7+ years of experience in pharmaceutical Regulatory Affairs including direct interactions with FDA.
Requires specific experience with biotech development products in oncology, immunology, or rare diseases.
Must have business expertise with US Regulatory Affairs and drug development, including development of regulatory strategy at the preclinical and clinical stages.
Solid knowledge of FDA processes from beginning to end required.
Must have experience with the preparation and review of regulatory submissions.
Requires demonstrated expertise in FDA pre-IND and/or FDA IND filings.
Strong project management experience required.
Requires strong attention to detail composing and proofing materials, establishing priorities and meeting deadlines.
Must have exceptional communication skills, both written and verbal.
Requires strategic thinking in drug development with solid business acumen.
Creative problem solver.
Must have effective negotiating skills.
Ability to lead innovation and change.
If interested, please email your resume as a Word attachment to us, reference 4009. No calls 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.