What are the responsibilities and job description for the Manager, Regulatory Affairs US Advertising & Promotion, Oncology position at BioSpace, Inc.?
Job Details
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 at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
Job Description
The Manager Regulatory Affairs US Advertising & Promotion, combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. This individual has responsibility for 1-2 of the following : therapeutic area, products or multiple driver indications for a product. The Manager, develops and supervises regulatory professionals as needed, has department / group / site level influence and is generally recognized as an expert and resource within the department. In addition, supports the Director in efforts to influence the regulatory environment, shares knowledge and expertise with others in support of team activities, and analyzes broad scope implications of changing regulations and policies.
Responsibilities : Effectively presents pertinent information to appropriate cross-functional groups.Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.Provides inter-departmental direction and negotiation of regulatory issues. Independently recommends and implements changes to complex projects based on knowledge and expertise, accurate interpretation of government regulations, guidances, promotional guidelines, corporate policies and management related considerations.Responsible for high impact and visible departmental project(s). Provides leadership in problem solving with teams.Functions as the expert within the job function and the product / disease state. Rapidly understands, evaluates and identifies issues / problems.Develops and executes departmental and therapeutic area strategies.Mentors staff, contractors interns and / or rotational students.Employs rigorous logic and methods to independently and effectively / creatively solve difficult problems. Probes multiple sources for answers. Identifies hidden problems and issues beyond the obvious.Develops solutions for more complex issues with little guidance from managementProactively addresses and resolves issues having potential impact on working relationships and productivity.Uses problem solving skills to separate and combine tasks into efficient workflow, makes good decisions based upon a mixture of analysis, experience and judgment.Significant Work Activities : Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
Minimum : Bachelors degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) 6 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)Preferred : PharmD degree 3 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)Experience working in a complex and matrix environmentExhibits strong negotiation skillsStrong communication skills, both oral and writtenExperience in US Regulatory Affairs Advertising and Promotion preferredAdditional 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 Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
US & Puerto Rico only - to learn more, visit
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :
