Full-Time AD AD Promo-Regulatory Affairs
Associate Director Regulatory Affairs Ad/Promo
JR000010094 Associate Director Regulatory Affairs Ad/Promo (Open)
US Specialty Brand Headquarters – USA501
SUMMARY OF POSITION:
The Associate Director, Advertising/Promotion Regulatory Affairs will be responsible for overseeing the regulatory assessment and research on regulatory precedence, in order to evaluate advertising/promotional regulatory issues for various Mallinckrodt products; develop and review regulatory strategies for promotional materials for marketed and pipeline products; provide regulatory input to various functional units on promotional labeling for marketed and to-be marketed drugs, and serve as a the lead regulatory affairs representative on the PRC committee.
•Provide regulatory technical support and supplement leadership and guidance to the marketing team during the development, review and approval of product labeling and advertising materials.
•Assist the Sr. Director of Regulatory Services in regulatory oversight related to advertising and promotional activities within Mallinckrodt
•Work directly with each of the marketing teams from concept through review and approval, up to and including DDMAC/OPDP submissions.
•Provide input on the promotional review committee (PRC) for regulatory review of all product labeling and advertising materials.
•Work collaboratively with Compliance to ensure that materials approved by PRC are used within the intended guidelines.
•Work with the Sr. Director of Regulatory Services to review and approve non-promotional items such internal training documents and internal communications
•Represent the company to outside customers and agencies and make presentations as needed on current regulatory issues pertaining to Advertising and Promotional activities.
•Review content and format of documents, assuring compliance with corporate policies, federal regulations and guidelines, and product development objectives.
•Interact effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that timelines are met.
•Provide oversight of regulatory document control activities.
•Work collaboratively with medical and scientific personnel on development and review of materials related to advertising and promotion.
•Participate in training of sales and marketing personnel on promotional, marketing, labeling and advertising regulations.
•Serve as a FDA liaison for matters related to advertising and promotion.
Other Position responsibilities:
•Work with other regulatory team members to provide input into improvement of systems and/or processes.
•Provide insight into current directions in the regulatory environment, such as updates on warning letters, FDA meetings etc.
•Review current policies and practices issued by Federal regulatory agencies and update management as needed.
•Review regulatory guidelines and publications to keep apprised of new regulatory developments.
•Receive project assignments from supervisor but has responsibility for managing timelines for projects with minimal supervision.
•Provide regulatory-based recommendations on marketing project initiatives and make recommendations for improvements for existing projects.
•Bachelor’s Degree (B.S.) in a life sciences or technical field from an accredited university and a minimum of five (5) years related experience in Regulatory Affairs.
•At least Four (4) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
•Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities.
•Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills.
•Proven ability to prioritize and meet project deadlines.
•Ability to determine essential components of requirements in order to include them in applicable policies and procedures.
How to Applyhttps://mallinckrodt.wd5.myworkdayjobs.com/en-US/MallinckrodtCareers/job/US-Specialty-Brand-Headquarters---USA501/Associate-Director-Regulatory-Affairs-Ad-Promo_JR000010094
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