Associate Director, Regulatory Affairs
celgene - Berkeley Heights, NJ

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Prerequisites: BS or MS in scientific discipline or equivalent 59 years pharmaceutical industry with 35 years in regulatory. Advanced degree preferred. Summary: Responsibilities will include, but are not limited to, the following: Manage regulatory aspects of PostMarketing regulatory submissions and communications with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) [formerly the Division of Drug Marketing, Advertising and Communications (DDMAC)]. Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of Celgene’s products.

Manage timelines and resources to achieve stated goals. 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 productrelated teams and the Copy Review Committee (CRC). Foster and facilitate teamwork between GRA and these allied functions. Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials and press releases.

Provide leadership for and manage regulatory aspects of the copy review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion. Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products. Proactively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape. Provide colleagues in GRA and allied functions with cutting edge guidance on requirements and changes.

Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between Celgene and FDA. Work closely with the GRA rep on Project Teams to support A&P Activities. Skills/Knowledge Required: BS or MS in scientific discipline or equivalent. Advertising and Promotional experience is a must.

59 years of pharmaceutical industry experience, including 35 years in regulatory affairs. Preference for at least 3 years experience in postmarketing regulatory affairs, specifically pharmaceutical promotional activity. Knowledge of Advertising and Promotional FDA regulations and experience with FDA communication and contact is necessary. Excellent interpersonal skills and written and oral communications skills.

Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously. Must be able to innovate, analyze, and solve problems with minimal supervisory input. Able to accommodate modest amount of domestic travel. Ability to manage multiple responsibilities with high degree of selfmotivation.

CareersInPharmaceutical.com - 21 months ago - save job
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About this company
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Celgene is delivering innovative therapies to patients with unmet medical needs in cancer and inflammatory diseases.