Our client is a global biopharmaceutical company that is a leading supplier of vaccines. They have asked us to assist them in their search for a Senior Director, Regulatory Affairs.
Major tasks and responsibilities will include:
Serves as a member of the Global Regulatory Affairs (GRA) Leadership Team.
Contributes to the vision and goals for the GRA team.
Ensures that objectives are aligned.
Leads the regional regulatory teams, regional colleagues and other partners to create and implement regulatory strategies and plans for the region.
Serves as liaison for the company with the North American regulatory agencies.
Establishes regulatory credibility for the company.
Maintains relationships with regulatory agencies in order to facilitate a positive and collaborative dialogue and enables the timely delivery of regulatory outcomes consistent with the company strategy throughout all stages of the product lifecycle.
Advises senior and executive management on the regulatory climate and proposed changes by regulatory authorities, rules and regulations, policies and guidance that could impact the business.
We seek candidates with the following qualifications:
Advanced degree in Biological or Medical Science or Pharmacy required.
Must have a minimum of 15 years of pharmaceutical industry experience in regulatory management.
Requires expert strategic and tactical thinking ability, complemented by a hands on operational and business planning orientation.
Must have a balanced technical understanding of products and processes combined with superior business, regulatory and compliance acumen.
Superior judgment and strong analytical skills, for implementing risk-based oversight programs required.
Requires a proven track record of collaborating and influencing skills across the organization at all levels.
Must have excellent communication and interpersonal skills to ensure the needs of internal and external stakeholders are met.
The ability to lead, drive and motivate people to achieve goals is required.
Requires expert presentation skills
Domestic, regional and international travel required.
If interested, please email your resume as a Word attachment to us, reference 3944. 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 Scanlons list of Top 50 Healthcare & Life Sciences Search Firms.