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Senior Director, Regulatory Affairs

Raptor Pharmaceuticals

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Location: Novato, CA Posted Date: 4/11/2013 Position Type: Full time Job Code: Senior Director, RA Required Education: Bachelors Degree Areas of Expertise Desired: Biology
Chemistry
Engineering
Regulatory Affairs

Description

The Senior Director, Regulatory Affairs is responsible for pre- and post-approval regulatory compliance for advertising, labeling, and promotional information, along with strategy, leadership, planning and execution for Raptor Pharmaceuticals.  The Senior Director will lead and implement our regulatory efforts in providing OPDP reviewers advertising and promotional labeling to ensure that the information contained in these promotional materials is not false or misleading; in providing ongoing regulatory support for our commercial products, manage the compliance of all federal and state regulations and laws; support post-marketing requirements and commitments as it relates to supporting advertising and promotional materials after approval to gather additional information about a product's safety, efficacy, or optimal use.

Responsibilities
*Manage regulatory aspects of communications with Food and Drug Administration (FDA) and the Office of Prescription Drug Promotion (OPDP) and serve as communication liaison with OPDP Reviewers.
*Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales & Marketing and other product-related teams and the Promotional Review Committee (PRC). Foster and facilitate teamwork between RA and these allied functions.
*Work with Raptor allied functions to foster a business partnership environment between RA and sister functions in the review and approval of Raptor advertising and promotional materials.
*Provide regulatory expertise, advice, and feedback to commercial review teams on marketing concepts.
*Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of Raptor's products. Manage timelines and resources to achieve stated goals.
*Develop and implement Corporate and Department procedures and policies for regulation of marketed promotional materials and press releases.
*Lead and manage regulatory aspects of the promotional review / approval process for product promotional materials. Ensure compliance of promotional materials with governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion.
*Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Raptor's pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape. Provide colleagues in RA and allied functions with current guidance on requirements and changes.
*Foster collaborative, efficient, and effective working relations with FDA in order to further build the working relationship between Raptor and FDA.
*Lead preparation for and provide onsite leadership for Regulatory Agency Inspections with questions regarding Raptor's Advertising and Promotional Materials.
*Other duties as assigned.

Requirements

*4-year degree in Biological Sciences, Chemistry or Engineering required.  Advanced degree a plus.
*Experience: 10+ years in the pharmaceutical industry, including 7 years of direct regulatory affairs experience. 5+ years experience in post-marketing pharmaceutical promotional activity a plus.
*Experience in managing regulatory filings.
*Excellent written and verbal communication skills.
*Must be results oriented with strong regulatory, planning and execution skills.
*In-depth experience working with the principles and techniques of data analysis, interpretation and clinical relevance.
*Proven experience and effectiveness leading strategic regulatory activities.
*Ability to review regulatory and scientific submission documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.
*Must be able to work successfully within a team.
*Experience in leading regulatory strategies.
*Established relationships with global regulatory authorities.
*Some travel required.
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