AbbVie

Associate Director / Director Regulatory Affairs Area & Affiliate

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Feb 03, 2021
Ref
2101804
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Associate Director / Director Regulatory Affairs, Area & Affiliate is responsible for combining knowledge of scientific, regulatory and business skills to enable products that are developed, manufactured or distributed to meet required legislation. Responsible for the development and implementation of regional strategies, Area Regulatory Strategy and Tactical Plans (RSTP) in collaboration with key internal stakeholders within RA, ADT and other disciplines. Acts independently or under supervision of Senior Director. May serve as primary regulatory contact with Health Authorities. Develops, actively mentors and supervises regulatory professionals.
  • Assures that regulatory strategies, once defined within the GRPT in collaboration with ADT and endorsed by the RA LT are effectively implemented and maintained in line with changing regulatory and business needs.
  • Develops and implements internal standards in line with Area regulations. Effectively interfaces with Health Authorities including Senior personnel.
  • Assesses regulatory issues and strategies for potential regulatory/business implications in its geographic region for assigned therapeutic area. Anticipates emerging issues develops solutions and works in partnership with the GRPT to coordinate management of high profile/high criticality regulatory issues.
  • Creates and develops product positioning strategies based upon regulatory requirements. Integrates regulatory consideration into the corporation's global product entry and exit strategy.
  • Develops and manages/mentors people and processes within its therapeutic area. Serves as experienced resource within Area Regulatory. Provides guidance for resource and development planning.
  • Communicates application progress to internal stakeholders. Negotiates with regulatory authorities during the development and review process to ensure submission approval. Provides strategic input and technical guidance on regulatory requirements to development teams. Ensures preapproval compliance activities are completed. Formulates company procedures to respond to regulatory authority queries.
  • May represent A&A within cross-functional initiatives, bringing regulatory expertise and insights to projects sponsored by other business functions like Quality Assurance or Operations.
  • May represent regulatory affairs in product recall and recall communication process. Ensures adverse events are reported to regulatory agencies and internal stakeholders. Ensures adverse events are reported to regulatory agencies and internal stakeholders. Manages processes involved with maintaining annual licenses, registrations, listings, and patent information. Ensures compliance with product post-marketing approval requirements.
  • Reviews and approves disseminated information to minimize regulatory exposure and preserves confidentiality of applicable product information.

Qualifications
  • Required Education: Bachelor's degree (pharmacy, biology, chemistry, pharmacology,) or related life sciences
  • Preferred Education: Relevant Master's degree. Certifications a plus
  • Strong clinical foundation a plus
  • Required Experience: 10 years Regulatory, R&D, or industry related experience. 5+ years in quality systems and process improvement
  • Experience working in a complex and matrix environment. Extensive experience interfacing with government regulatory agencies
  • Strong communication skills, both oral and written
  • Preferred Experience: 5-7 years in pharmaceutical regulatory affairs. Proven 7-10 years in a leadership role with strong management skills
  • Experience developing and implementing successful global regulatory strategies. Experience working within a Health Authority

*Position is flexible based on experience

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.