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NE15146 - ASSOC. DIRECTOR, REGULATORY AFFAIRS-PROMOTIONS/ADV
Provides strategic regulatory advice on advertising and promotion materials and activities for assigned Cardiovascular products in accordance with business goals and objectives, FDA regulations, and company policy.
Serves as a primary regulatory advertising and promotion reviewer for assigned products on PRCs.
Liaison with DDMAC regarding advertising and promotion for assigned products.
Manages DDMAC queries on assigned products.
As active participant on Brand Teams, applies regulatory and therapeutic area knowledge to Brand Teams objectives and initiatives to develop solutions to complex US promotional issues.
Ensures regulatory compliance while effectively managing business risks.
Understands global promotional strategies and provides solutions to local US regulatory promotional issues.
Maintains awareness of competitor activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
Prepares complaint letters to DDMAC.
Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by DDMAC, and by attendance of major FDLI, DIA, and other industry/FDA meetings.
Establishes strong and positive working relationship with DDMAC reviewers.
Works with DRA PTR on IPT to insure that regulatory strategy will result in commercially viable US labeling on which future promotion and advertising will be based.
Participates in US labeling negotiations and FDA meetings as necessary.
Ensures that changes in US PI are reflected in the current promotions and advertising.

Minimum requirements:

BS degree or equivalent (PhD, PharmD, or JD preferred) with a minimum of five years experience in US Drug Regulatory Affairs.

Excellent understanding of US regulations for drug promotions, advertising, and US labeling.

Strong understanding of business goals of the involved Business Franchise, marketing concepts and tools.

Must perform independently with strong negotiation and decision making skills.

Must be able to work in multi-disciplinary environment

Must possess strong interpersonal skills.

Must have analytical and problem-solving skills associated with problem reviews and inquiries

Must be able to provide creative solutions to complex problems

Submit Your Resume


	Home Who We Are For Clients For Candidates Job Postings Resources Contact Us	NE15146 - ASSOC. DIRECTOR, REGULATORY AFFAIRS-PROMOTIONS/ADV Provides strategic regulatory advice on advertising and promotion materials and activities for assigned Cardiovascular products in accordance with business goals and objectives, FDA regulations, and company policy. Serves as a primary regulatory advertising and promotion reviewer for assigned products on PRCs. Liaison with DDMAC regarding advertising and promotion for assigned products. Manages DDMAC queries on assigned products. As active participant on Brand Teams, applies regulatory and therapeutic area knowledge to Brand Teams objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks. Understands global promotional strategies and provides solutions to local US regulatory promotional issues. Maintains awareness of competitor activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted. Prepares complaint letters to DDMAC. Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by DDMAC, and by attendance of major FDLI, DIA, and other industry/FDA meetings. Establishes strong and positive working relationship with DDMAC reviewers. Works with DRA PTR on IPT to insure that regulatory strategy will result in commercially viable US labeling on which future promotion and advertising will be based. Participates in US labeling negotiations and FDA meetings as necessary. Ensures that changes in US PI are reflected in the current promotions and advertising. Minimum requirements: BS degree or equivalent (PhD, PharmD, or JD preferred) with a minimum of five years experience in US Drug Regulatory Affairs. Excellent understanding of US regulations for drug promotions, advertising, and US labeling. Strong understanding of business goals of the involved Business Franchise, marketing concepts and tools. Must perform independently with strong negotiation and decision making skills. Must be able to work in multi-disciplinary environment Must possess strong interpersonal skills. Must have analytical and problem-solving skills associated with problem reviews and inquiries Must be able to provide creative solutions to complex problems Submit Your Resume