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Director, Regulatory Affairs Strategy-Facial Aesthetics, Pharma

Employer
AbbVie
Location
Irvine, California
Start date
Feb 20, 2024

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Job Details

Purpose:

The Director Regulatory Affairs Pharmaceuticals, Facial Aesthetics, is responsible for developing and implementing global regulatory strategies to secure and maintain market approval for product(s) and representing Regulatory Affairs on R&D Project teams.   Leads the dossier team, GRPT, and LRST for assigned projects.  Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers.  Serves as the primary regulatory interface with AST, IEST and other supporting teams. Proactively anticipates and mitigates regulatory risks.  Responsible for knowledge of regulatory requirements of major regions (US, EU, Japan and China) with responsibility for working with colleagues on a worldwide basis to form a global strategy and ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including pre-Phase 1, post approval and throughout the life cycle of the product. Demonstrates excellent understanding of drug development and leadership behaviors consistent with level.  Develops and implements acceleration strategies. Manages projects and necessary documentation of regulatory strategies, commitments, and obligations in compliance with regulations and company policies and procedures. Ensures alignment of global regulatory strategies with Sr. management.  Demonstrates leadership behaviors consistent with level, including operating with minimal guidance. May cover multiple developmental projects. May participate in initiatives.  May have direct reports.

Responsibilities:

·       Interfaces with the LRST and AST to lead and support cross-functional company objectives.  Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for development and marketed products. When necessary, seeks expert advice and technical support from functional stakeholders, supervisor, and TAH level personnel.

·       Leads cross-functional stakeholders and regulatory professionals to ensure inclusion of appropriate and clear strategic messaging in the content of global regulatory dossiers and responses to regulatory Agency requests. 

·       Accountable for ensuring that corporate goals are met. Key internal leader and driver of regulatory policy and strategy for assigned products.

·       Leads preparation of global regulatory product strategies for assigned products.  Proactively leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products and communicates plan to relevant stakeholders.

·       Acts independently under the direction of a Sr Director. 

·       May participate in or lead regulatory and Company initiatives. Based on experience and scientific strengths, expands knowledge of TA and provides coaching and mentoring for GRPT members. May have direct report(s) and contribute to the performance management for other RA team members.

·       Influences the development of regulations and guidance. Analyzes legislation, regulations, and guidance and provides analysis to the organization, with worldwide accountability for assigned products.

·       Follows company policies and procedures for regulatory record keeping and may identify need for and develop and implement policies and procedures within the RA department and, if applicable, ensure direct reports follow requirements.

·       Ensures alignment of global regulatory strategies with Sr. Management.  Under minimal guidance of supervisor, presents meaningful regulatory assessments and regulatory recommendations to executive management.  Proactively informs AST and cross functional management, including RDLT and Commercial Leadership of issues, labeling outcomes, approval or other risks and mitigations. Provides assessment of impact on global programs. Represents ABBV Regulatory position in interactions at Joint Governance committees with partnered assets. Provides informed regulatory opinion based on experience and expertise. Independently leads governance discussions, including representing cross-functional points of view and presents at other governance forums including APGB, CFG, Toxin Board and Toxin Office.

·       Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects.

·       Follows budget allocations and keeps supervisor informed on project resourcing (headcount-related fees, filing fees, and professional services).

·       Chairs or sponsors key regulatory initiatives and presents outcomes to Regulatory leadership team.

·       Provides leadership and development to direct reports.


Qualifications:

·       Required Education: Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology or related subject preferred).

·       Preferred Education: Relevant advanced degree is preferred. Regulatory certification a plus.

·       Required Experience: 7+ years regulatory experience.  Some portions 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 5+ years in a strategic leadership role with strong project management skills. Experience working in a complex and matrix environment with multiple stakeholders and influencing cross-functional teams.  Experience interfacing with major government regulatory agencies.

·       Required Experience cont'd: Strong communication and proactive negotiation skills.  Experience developing and implementing successful global regulatory strategies.

·       Preferred Experience: 10+ years’ experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU or Japan. Strong global drug development foundation with business acumen.

·       Note: Higher education may compensate for years of experience.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

·      The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

·      We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

·      This job is eligible to participate in our short-term incentive programs. 

·      This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.


Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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