AbbVie

Director, Regulatory Affairs CMC (Biologics)

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Nov 20, 2020
Ref
2008593
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 Director, RA CMCC (Biologics) is responsible for combining knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured, or distributed to meet global regulatory requirements. Works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including new marketing applications, supplements and variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research and Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Label and Regulatory Strategy Teams to negotiate, influence, and provide strategic advice. Serves as liaison and strategic partner with the regulatory agencies (e.g., FDA). Manages assigned projects within assigned resources. Has influence and responsibility and is a key leader and a driver of regulatory policy and strategy. Influences the development and changes of regulations and guidance. Interfaces with outside regulatory agencies and trade associations and provides executive management with regulatory metrics and information. Individual may plan, direct, coordinate and control regulatory affairs activities related to products worldwide. May supervise others, in which case will develop, actively mentor and supervise global regulatory professionals who develop strategy for development and marketed products, and manage the content of global regulatory dossiers.

Key Responsibilities Include :
  • Identifies and collects data needed and prepares CMC regulatory product strategies. Seeks expert advice and technical support as required for strategies and submissions. Makes decisions and provides guidance for support of products including combination products.
  • Manages the preparation of CMC submissions. Prepares and manages regulatory applications, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.
  • Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
  • Develops strategies for CMC meetings, manage preparation for agency meetings and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.
  • Trains, develops and mentors individuals; may include formal supervisory responsibilities.
  • Develops and implements policies and procedures within the regulatory affairs department. Provides leadership to organizational staff by communicating and providing guidance towards achieving department objectives.
  • Analyzes legislation, regulation, guidance and standards, and provides analysis to management and to the organization.
  • Influences the development of regulations and guidance. Advances the organization's goals by participating and taking leadership roles in professional associations, industry and trade groups as appropriate for assigned projects.
  • Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Label and Regulatory Strategy teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions.
  • Represents CMC regulatory affairs on project initiatives with other groups to drive efficiencies across the company. Develops, communicates and builds consensus for operating goals that are in alignment with the company.
  • Supports combination products and medical devices including design control and change management activities

Qualifications

Qualifications:

Basic:
  • Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
  • Preferred Education: Relevant advanced degree preferred.
  • Required Experience: 12+ years pharmaceutical or industry related experience. 5+ years in quality systems and process improvement or regulatory affairs. Proven 7+ years in a leadership role with strong management skills
  • Preferred Experience: Experience with biologics
  • Experience working in a complex and matrix environment.
  • Strong communication skills, both oral and written.
  • Preferred Experience: 8+ years' experience in CMC Regulatory Affairs. 12+ years pharmaceutical experience (drug/medical device/combination product).
  • Experience developing and implementing successful global regulatory strategies. Experience working with Health Authority
  • Note: Higher education may compensate for years of experience

Grade: 21

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 10 % of the Time
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.