AbbVie

Associate Director, Global Regulatory Strategy

Employer
AbbVie
Location
Sunnyvale, CA, United States
Posted
Feb 21, 2021
Ref
2100628
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 Global Regulatory Strategy, under the accountability of the Global Regulatory Lead, defines and implements regulatory strategies and priorities, in conjunction with the Global Regulatory Product Team (GRPT) as appropriate. Supports teams and efforts around major filing activities and health authority interactions and meetings. Provides regulatory support to other departments, project teams, and committees. Organizes/manages submissions to health authorities, including INDs/CTAs, IND/CTA amendments, pediatric study plans, orphan drug applications, breakthrough therapy applications, safety reports, pre-meeting packages, and supplemental NDA submissions. Ensures application of established policies and best practice regulatory standards within applicable geographic region(s).

Responsibilities
  • Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction. Sets strategy and leads cross-functional/multidisciplinary therapeutic teams and multidivisional initiatives. Operates independently, with recognition of when to consult departmental senior staff concerning risks and opportunities.
  • Collects and analyzes issues/trends that affect business to identify and act on cross-organization or cross business opportunities. Uses knowledge of global marketplace, technology and business levels effectively.
  • Represents Regulatory Affairs (RA) at project team meetings and manages/oversees regulatory workflow between departments as well as CROs as required at the study team level.
  • Leads and facilitates development of Health Authority (HA) meeting requests and briefing packages in preparation for HA meetings.
  • Manages the preparation and review of regulatory submissions to assure effective presentation of data, complete and timely response to Health Authority during application review, and quality consistent with Health Authority regulatory requirements and guidelines.
  • Helps lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports).
  • Leads and facilitates development of US pediatric regulatory strategy to support fulfillment of a pediatric written request and supports completion of global pediatric regulatory commitments.
  • Oversees development of dossier filing plans and associated timelines with regulatory operations lead.
  • Provides oversight to filing and study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications.
  • Leads and facilitates team preparation for FDA meetings.
  • Leads and facilitates USPI labeling activities with cross-functional team for planned regulatory filings.
  • Manages direct reports and/or assists in the development, training, and mentoring of staff members (RA [Sr] Managers and/or [Sr] Associates), as applicable. Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development.
  • Solid understanding of regulations and guidance of regulatory authorities, political and legal climate and industry practices to assist in meeting organizational goals. Possesses and leverages broad industry knowledge. Coordinates and prepares submissions in line with Health Authority regulatory requirements and guidelines.

Qualifications

Qualifications
• Required Education: Bachelor's Degree (pharmacy, biology, pharmacology) or related life sciences
• Preferred Education: Relevant advanced degree is preferred (eg PhD). Regulatory certification a plus
• Required Experience: 5 years Regulatory, R&D or related industry experience
• Extensive experience interfacing with government Agencies and Health Authority personnel. Experience working in a complex and matrix environment
• Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization. Strong communication skills, both oral and written
• Preferred Experience: 5 years in regulatory pharmaceutical affairs
• Strong leadership presence with prior management experience
• Experience developing and implementing successful global regulatory strategies

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
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.