Director, Regulatory Affairs Advertising & Promotion (On-site or Remote)

Allergan; Lincoln (NE); Remote; USD 120,000 - 160,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Director of Regulatory Affairs, US Advertising and Promotion. This role is crucial for implementing and overseeing regulatory strategies for advertising and promotions. Candidates should possess a robust background in pharmaceutical regulations, strategic planning, and possess strong leadership capabilities, having worked extensively in the advertising and promotion sectors. The position offers competitive compensation and is located in Lincoln, Nebraska.

Benefits

Paid time off

Medical/dental/vision insurance

401(k) plan

Participation in short-term incentive programs

Participation in long-term incentive programs

Qualifications

• 10 years of pharmaceutical experience required.
• 5 years direct advertising and promotion review experience preferred.
• Solid understanding of regulatory advertising and promotion regulations.

Responsibilities

• Implement regulatory advertising and promotion strategies.
• Advise cross-functional teams on content and message consistency.
• Review and approve advertising and promotional materials.

Skills

Regulatory knowledge

Strategic planning

Communication

Team leadership

Education

Bachelor's Degree in science

Master’s, Ph.D. or Pharm D preferred

Job description

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Director Regulatory Affairs, US Advertising and Promotion is responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching regulatory strategy and brand plan. He/she will contribute to strategic planning for the department (and departmental achievement of initiatives to meet goals and plan), manage assigned projects, and develop individual and team performance within the assigned franchise. He/she will also network and benchmark outside of AbbVie to provide for best practices and processes.

Responsibilities

• Advisecross-functional teams on content and message consistency and best practices regarding planning and execution of marketing strategies.
• Assurethat cross-functional advertising and promotion review teams are operating according to approved company processes and procedures.
• Be responsible for the training of regulatory staff, as required.
• Provideregulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies.
• Conductreview and approval of professional and direct to consumer advertising and promotion and providing comments to review teams.
• Effectively lead and establish strong working relationships with cross-functional review teams, both internal and with co-promotional partners. Serves as leader of cross-functional promotion review team meetings.
• Possess strong working knowledge of DDMAC guidance and applies understanding to business situations.
• Based upon sound regulatory knowledge, makeand executechallenging decisions,understandingwhen a decision should be elevated to upper management for further consideration.
• AdviseRegulatory Operations group regarding special requirements for FDA 2253 submissions.
• Workclosely with RA labeling group regarding package insert changes to assure that promotional PI and important safety information are updated as appropriate.

Qualifications

As a qualified candidate, you must posses a Bachelor's Degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology). AMaster’s, Ph.D. or Pharm D is preferred.

You should also posses 10 years of pharmaceutical experience, with 5 years direct advertising and promotion review experience. While 5 years advertising and promotion regulatory experience is preferred, medical/scientific affairs experience may be considered.

Having already worked directly in this area, you must have a solid understanding of regulatory advertising and promotion regulations.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html