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 onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, multidisciplinary, therapeutic teams, and executing multidivisional initiatives for labeling activities for drugs, devices and combination products in assigned therapeutic area(s).
Collects and analyzes labeling issues and trends that affect the business.
Possesses and leverages solid understanding of labeling regulations, opinions and guidances of regulatory authorities, political and legal climate and industry practices to ensure that organizational goals are met.
Operates independently with recognition of when to consult upper management concerning potential risk.
Establishes labeling policy compliant with changing regulatory environment.
Manages labeling staff for assigned therapeutic area(s).
Responsibilities
Develops and directs regulatory labeling strategy planning for or across assigned product group and ensures labeling strategies are in-line with business needs.
Presents process, strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings (Global Regulatory Forum (GRF), Executive Labeling Committee (ELC), Steering Committee)Leads cross functional labeling teams including regulatory, clinical and safety.
Manages labeling history and negotiation documentation for assigned products.
Provides labeling strategy and direction to teams involved in agency activities.
Leads resolution for labeling issuesEnsures that agreed regulatory strategies or commercial concepts are efficiently implemented in labeling documents, and that labeling strategies are maintained in-line with changing regulatory and business needs.
Ensures labeling documents meet R&D and commercial needsDevelops and implements internal and/or external strategies to proactively influence legislation/ guidelines with impact on AbbVie business, and to address changes in the regulatory environment.
Represent company with regulatory agencies on labeling policy topics.
May represent company at inspection activities for labeling topicsEnsures standard interpretation of regulations across projects.Develops and manages an effective team.
Conducts succession planning.
Manages the work of direct reports.
Trains new personnel and provides input to new department processes/policiesRepresents company at external labeling meetings with partner companies or industry associations Qualifications
Qualifications
Required Education: Bachelor's Degree in Pharmacy, Biology, Chemistry or MicrobiologyPreferred Education: Relevant Master's degree preferred.
Certification in regulatory affairs a plusRequired Experience: 10+ years pharmaceutical, regulatory or industry related experience.
8 years in pharmaceutical experience.
Proven 3-5 years in a leadership roleExperience working in a complex and matrix environmentStrong communication skills, both oral and writtenStrong management skills and multi-disciplinary team managementExperience working with Health AuthorityNote: Higher education may compensate for years of experienceThis role can sit out of Lake County, IL, Florham Park, NJ, or Irvine, CA. 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, serving our community and embracing diversity and inclusion.
It is AbbVie's 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, 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
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