Director, Global Regulatory Lead (Virology & Established Products)
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, Global Regulatory Lead develops and implements global, US and Canadian regulatory strategies to secure and maintain market approval in the assigned therapeutic area. The Director leads the Global Regulatory Product Team (GRPT), expands Therapeutic Area (TA) knowledge, and handles messaging and content of dossiers. Additionally, this person proactively anticipates and mitigates risks, ensures compliance with global regulatory requirements, and demonstrates understanding of drug development.Responsibilities
- Leads a team of global regulatory professionals for development and marketed products. Accountable for ensuring that goals are met.
- Leads preparation of product strategies, and leads team in the preparation and maintenance of risk assessment and mitigation strategy development.
- Acts independently under the direction of a Global Regulatory Strategy (GPS) TA Head. May participate in or lead initiatives.
- May have direct report and contributes to the performance management for other RA team members.
- Influences the development of regulations and guidance. Advises management of the effect of current or proposed laws, regulations, guidelines and standards, etc.
- Advises internal personnel on regulatory strategies. Follows company policies and procedures for regulatory record keeping and ensures direct reports follow requirements.
- Ensures alignment of strategies with Sr. Management. Proactively informs ADT and management of issues, risks and mitigations, and provides informed regulatory opinion based on experience and expertise.
- Works with GRPT to develop, and communicate goals that are in alignment with the business goals.
- Under supervision of a Director or TA Head, communicates to team and cross-functionally the immediate to long-range plans to carry out objectives established by executive management.
- Advances the organization’s goals by participating and taking leadership roles in professional associations, industry and trade groups for assigned projects.
- Follows budget allocations and keeps supervisor informed on project resourcing.
Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.
- Preferred Education: Relevant advanced degree is preferred. Certification a plus.
- Required Experience:7+ years regulatory experience. Some portion may include experience related to pharmaceutical regulatory work (e.g., other R&D role or specialized training). Requires drug development experience in US&C region. Proven 3-5 years in a leadership role with strong management skills. Experience working in a complex and matrix environment with multiple stakeholders and on cross-functional teams.
- Required Experience cont'd: Strong communication and proactive negotiation skills. Experience contributing to enterprise management of a portfolio of products. Experience interfacing with government regulatory agencies. Experience developing and implementing successful global regulatory strategies.
- Preferred Experience:10 years’ experience in pharmaceutical regulatory activities; preferably with experience as lead regulatory product strategist in two or more major regions such as EU or Japan. Strong clinical foundation preferred with business acumen. Note: Higher education may compensate for years of experience.
Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Yes, 25 % of the Time
Job Level Code
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.