AbbVie

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.. The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation.. Represents the organization at Senior level meetings regarding Target Product Label (TPL), Development Core Data Sheet (DCDS), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics (EU SPCs) and other Global Labeling.. Provides labeling input for Risk Management Plans, Regulatory Strategic and Tactical Plan (RSTPs) and safety document.. Required Education: BS or BA degree in a technical area (biology, chemistry, engineering, microbiology, immunology, medical technology, pharmacology,)

associate director regulatory affairs

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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. Influences the department and is recognized as an expert resource on label topics. Ensures that labeling data is identified, obtained, and effectively presented for the registration of products worldwide. Represents the organization at Senior level meetings regarding Target Product Label (TPL), Development Core Data Sheet (DCDS), Company Core Data Sheets (CCDS), US Package Insert (USPI), European Summary of Product Characteristics (EU SPCs) and other Global Labeling. Under the direction of the Director of Strategic Labeling, establishes labeling policy compliant with changing regulatory environment. Manages labeling staff. Develops and supervises regulatory personnel.
Responsibilities:
* Develops and directs regulatory label planning for or across assigned product group, area or operational activity and ensures they are in-line with business needs.
* Presents process, strategy, and product labeling at Senior level meetings (Global Regulatory Forum (GRF), Executive Leadership Committee (ELC), Common Technical Document (CTD) steering committee) and joint company meetings.
* Ensures that agreed regulatory labeling strategies or commercial concepts are efficiently implemented, and that strategies are maintained in-line with changing regulatory and business needs.
* Drives strategic labeling processes within teams based on knowledge of success with other products. Proactively recommends optimal label language based on competitive knowledge and knowledge of project data.
* Works cross functionally with teams such as Research & Development (R&D) and commercial to meet regulatory labeling needs. Provides labeling input for Risk Management Plans, Regulatory Strategic and Tactical Plan (RSTPs) and safety document.
* Comments on changing regulation and guidance, interfaces with outside regulatory agencies and trade associations and provides executive management with regulatory metrics/information.
* Develops and implements internal and external strategies to proactively address changes in the regulatory labeling environment.
* Under the direction of the Director, Global Labeling, provides regulatory leadership and expertise to licensing colleagues for labeling topics.
* Develops and manages an effective team. Conducts succession planning.
* Manages the work of direct reports. Trains new personnel and sets direction for development of new department processes/policies. Leads cross functional teams including regulatory, clinical and safety on labeling topics.
Significant Work Activities -Keyboard use (greater or equal to 50% of the workday)
Qualifications
Qualifications:
* Required Education: BS or BA degree in a technical area (biology, chemistry, engineering, microbiology, immunology, medical technology, pharmacology,)
* Preferred Education: Advanced degree preferred. Certifications a plus
* Required Experience: 8 years pharmaceutical, regulatory or industry related experience.
* Experience working in a complex and matrix environment. Strong communication skills, both oral and written
* Preferred Experience: 5+ years in industry related experience
* Understanding of regulatory concepts-knowledge of medical and regulatory terminology, guidelines, standards, etc.
* Experience developing and implementing successful global regulatory labeling strategies.
* Note: Higher education may compensate for years of experience
Additional Information
Applicable only to applicants<br/><br/>#J-18808-Ljbffr

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