Vice President, Regulatory Affairs
Responsibilities:
Manage regulatory affairs strategy and activities including FDA interactions, advisory panel meetings, submissions, REMS programs, labeling negotiations with the FDA, clinical trials, interacting with international regulatory agencies, participate in product evaluation for acquisition candidates, etc.
Manage all regulatory activities including review and timelines for regulatory submissions, regulatory submissions, promotional materials for marketed products to ensure compliance, and relations with regulatory agencies.
Requirements:
X BS / MS Degree or Doctorate in a scientific discipline
X Experience in pharmaceutical and/or biotechnology industry with marketed products.
X 5+ years experience at the VP level
X Proven track record in setting and managing regulatory strategy, with strong FDA regulation knowledge.
X Experience managing regulatory consultants both international and domestic is desired.
X Strong technical writing and verbal communication skills.
X Hands-on, results oriented, and team player.
X Excellent planning and organizing skills.
X 10-25% travel required
Company offers competitive salary, bonus and stock options, as well as a phenomenal benefits package.
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