Senior Director, Regulatory Affairs Advertising and Promotions at HAYS in Gaithersburg, Maryland

Posted in Other 4 days ago.





Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.


An American Company is seeking a Senior Director, Regulatory Affairs Advertising and Promotions in Gaithersburg, MD.


Role Description


We are seeking a highly motivated and experienced individual for a Director/Senior Director, Regulatory Affairs, Global Advertising and Promotion position to lead and build a global labeling group within our Regulatory Affairs organization. This position is located at our Gaithersburg, MD facility and will report to the Vice President of Regulatory Affairs. This position will develop, manage, and execute global labeling strategy working in close collaboration with cross-functional teams across the organization.


• Oversee/ensure commercial and promotional materials are consistent with guiding principles, PhRMA guidelines, FTC guidelines, and applicable FDA regulations and guidance's
• Directs/provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
• Oversees/Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.
• Manages FDA activity including enforcement actions, guidance documents, etc. to analyze and assess impact on company products and communicates risk to MRC(s).
• Hires/Trains regulatory staff as required.
• Monitors competitor advertising to keep abreast of market promotional and advertising strategies and assesses potentially violative competitive materials for forwarding to the FDA Office of Prescription Drug Promotion (OPDP) or Advertising and Promotion Labeling Branch (APLB) as appropriate.
• Continually assesses advertising and promotion - related processes and procedures to enhance efficiencies and compliance.
• Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.


Skills & Requirements


• Minimum requirements:
• Advanced academic qualifications/degree such as Pharm.D., Ph.D. are an advantage but not essential.
• A minimum of 12 years in the drug development industry with at least 10 years in Regulatory Affairs prescription product advertising and promotion expertise
• Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.
• Demonstrated ability to interpret and apply global and local regulatory guidance around advertising and promotions and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
• Excellent communication skills, both oral and written
• Strong interpersonal skills with the ability to influence others, without authority, in a positive and effective manner
• Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns
• Proven aptitude to analyze and interpret efficacy and safety data
• Experience communicating and negotiating with APLB or OPDP
• Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
• Excellent written and verbal communication skills essential.
• Demonstrated project management skills and attention to detail required.
• Proven ability to negotiate, influence and problem solve across a highly matrixed team.
• Ability to travel (domestic and international) up to 10%


Key Skills and Competencies:
• Knowledge of global/regional regulations and guidelines pertaining to Advertising and Promotions and demonstrated ability to decipher and understand implications of regulation changes and updates
• Demonstrated knowledge and understanding of company Core Data Sheets, Core Safety Information documents and the dynamics of Labeling Team purpose and objectives.
• Able and willing to work in a fast-paced environment while handling multiple priorities.
• Shows strong initiative and drive. Must be an organized self-starter.


Why Hays?


You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.


Nervous about an upcoming interview? Unsure how to write a new resume?


Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.


Hays is an Equal Opportunity Employer.


Drug testing may be required; please contact a recruiter for more information. #1129953


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