Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
Responsible for assisting and/or leading the development and, implementation of regulatory strategies for assigned products across a range of therapeutic areas, which may include both in-development (brand and generic) and marketed products. Support priority projects with limited supervision and lead other regulatory related activities (i.e. FDA milestone meetings, regulatory risk assessments, core development team meetings, etc.).
Participate and lead activities for the Regulatory Intelligence program for global regulatory affairs. The regulatory intelligence program consists of researching, analyzing, interpreting, communicating and acting on intelligence relative to the regulatory landscape, submission routes and existing and/or emerging competitor products to drive compliance and competitive advantage.
Develop and lead regulatory strategies independently for projects of moderate to high complexity. Formulate regulatory recommendations considering precedent, constraints, risks, and value to be communicated to regulatory management and project teams.
Direct interaction with FDA and potentially other regulatory agencies throughout the development lifecycle of projects, including leading regulatory agency meetings, teleconferences, etc.
Independently working with cross functional Teams, lead the strategic content development and preparation of high quality regulatory submissions that meet regulatory and departmental guidelines, including but not limited to regulatory meeting requests/briefing packages, ANDAs, INDs, NDAs, supplements, amendments, and variations.
Maintain current knowledge of global regulatory environment and lead activities for Regulatory Intelligence program
Research, review and interpret regulatory environment surrounding related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings, to support the development of optimal regulatory strategies that support successful submissions and achievement of target product labeling.
Perform and/or oversee surveillance for legislation/guidance, regulatory and competitor information
Identify the impact of regulatory intelligence information on products, programs or regulatory practices
Summarize, analyze and communicate regulatory intelligence and the potential impact
Ensure appropriate response plans are established and monitored to closure
Coordinate reviews of regulatory intelligence, ensuring alignment on position between all affected functions
Establish and maintain an effective regulatory intelligence database to track information and response plans
Develop and maintain relationships with external industry associations, and other pharma/technology companies to exchange information and influence regulatory/industry trade association initiatives
May conduct Regulatory review of promotional materials and provide guidance to the Team to allow informed risk-based decisions.
Demonstrate excellent leadership, communications, and interpersonal skills. Knowledge of regulatory requirements, guidances and regulations (US and international) within the pharmaceutical industry is desirable, knowledge specific to the Noven areas of clinical research and product development is desirable. Experience with IND and/or NDA/sNDA/ANDA filings, general submissions along with Regulatory Intelligence activities is highly desirable.
Education & Experience:
A minimum BS/BA Degree preferably in life sciences. A higher degree (Masters, PhD, PharmD) and/or RAC certification is preferred. At least 3-5 years regulatory or related experience in pharmaceutical industry.
Internal Number: 0047
About Noven Pharmaceuticals
Noven Pharmaceuticals, Inc. is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. We are committed to developing and offering products and technologies that meaningfully benefit patients, our customers and our industry partners.
Approximately 700 Noven colleagues are working to advance our business and benefit patients at locations in Miami, FL, New York, NY, Carlsbad, CA, and in sales force territories located across the U.S. We are a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., the world’s largest manufacturer of transdermal patches, and we serve as Hisamitsu's growth platform for U.S. prescription pharmaceuticals.
Noven maintains state-of-the art, FDA-approved transdermal manufacturing facilities in Miami and Carlsbad with capacity to produce over 500 million patches per year. These facilities are also approved by the U.S. DEA (Drug Enforcement Agency) for the production of controlled substances.
Noven’s commercialized transdermal products include Minivelle® (estradiol transdermal system), the planet’s smallest estrogen patch; CombiPatch®(estradiol/...norethindrone acetate transdermal system), the first approved combination (two-drug) patch; Daytrana® (methylphenidate transdermal system), the first and only patch approved for the treatment of ADHD; and a fentanyl transdermal system indicated for chronic pain. Our commercialized oral products consist of Stavzor® (valproic acid delayed release capsules), Pexeva® (paroxetine mesylate), and Lithobid® (lithium carbonate).