Description

Job Title
Associate Director/Director Regulatory Affairs Ad/Promo (Bedminster NJ)

Requisition

JR000010188 Associate Director/Director Regulatory Affairs Ad/Promo (Bedminster NJ) (Open)

Location

US Specialty Brand Headquarters - USA501

Additional Locations

Bedminster, NJ

Summary Of Position

Job Description

The Associate Director/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.

Responsibilities

ESSENTIAL FUNCTIONS:

• 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.

Minimum Requirements

Associate Director

Education

• Bachelor

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