Director, Global Regulatory Lead
1 month ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy, is responsible for developing and implementing globalstrategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the primary regulatory interface with AST and supporting teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages compounds through all phases of development, including 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 reg strategies.
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 GRS Sr GRL or TA Head. 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 membersInfluences 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 GovernanceMakes decisions regarding work processes or operational plans and schedules to achieve the program objectives established by senior management. Advances the organizations 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 sponsor key GRS initiatives and presents outcomes to RA LT.Qualifications
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 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 regulatoryRequired 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.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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. US & Puerto Rico only - to learn more, visit
-
Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full timeJob Summary:The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. This role involves preparing and reviewing submissions and working closely with cross-functional teams within the company and across business partners.Key...
-
Senior Director, Global Market Access Lead
23 hours ago
Chicago, Illinois, United States Argenx Full timeAbout ArgenxArgenx is a biotechnology company dedicated to transforming immunology and delivering medicines that help autoimmune patients regain control of their lives. Our mission is to push the boundaries of innovation and make a meaningful impact on the lives of patients worldwide.Job SummaryWe are seeking a highly skilled Senior Director, Global Market...
-
Global Director of Continuous Improvement
1 month ago
Chicago, Illinois, United States Nelson Global Products Inc. Full timeCompany Overview:Nelson Global engineers, manufactures, and distributes clean and efficient Air & Fluid Transfer, NVH, Complex Structural, Acoustic, and Thermal Management Solutions. Nelson Global partners with the world's leading OEMs. With 21 global manufacturing and distribution facilities and unparalleled engineering and innovation capabilities, Nelson...
-
Regulatory Affairs Coordinator
2 weeks ago
Chicago, Illinois, United States PSG Global Solutions Full timeWe are seeking a Regulatory Affairs Associate to join our team at PSG Global Solutions, specializing in the Biotechnology and Medical Devices sectors.Position Overview:In this role, you will be responsible for managing the submission of essential applications and overseeing all interactions with regulatory bodies related to the approval process for products...
-
Regulatory Validation Specialist
2 weeks ago
Chicago, Illinois, United States Northern Trust Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
-
Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full timeAbout the RoleMeitheal Pharmaceuticals Inc is seeking a highly experienced Senior Director of Regulatory Affairs, Specialty Pharmaceuticals to lead our regulatory strategy for specialty pharma products. This is a critical role that will play a key part in the growth and transformation of our regulatory team.Key ResponsibilitiesRegulatory Strategy: Provide...
-
Director, Global Alliance Leader
1 month ago
Chicago, Illinois, United States AbbVie Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care and products and services in our...
-
Director, NERC Regulatory Services
1 month ago
Chicago, Illinois, United States Invenergy Full timeInvenergy drives innovation in energy. Powered by decades of entrepreneurial experience and unparalleled execution, we solve the energy challenges facing our customers and communities. We provide power generation and storage solutions at scale around the world to create a cleaner energy future. We develop. We build. We own. We operate. We are Invenergy.Job...
-
Director of Global Development and Partnerships
21 hours ago
Chicago, Illinois, United States The University of Chicago Full timeAbout the RoleThe University of Chicago is seeking a highly skilled and experienced professional to serve as the Director of Global Development and Partnerships. This key leadership position will play a critical role in advancing the University's global reach and partnerships.Key ResponsibilitiesDevelop and implement a comprehensive global strategy to...
-
Freelance Creative Director
2 months ago
Chicago, Illinois, United States Current Global Full timeJoin our team at Current Global, a global communications agency that values humanity in everything we do. We are part of the Interpublic Group of Companies and The Weber Shandwick Collective, making our mark across different regions and industries. Our diverse team collaborates to create strategic and creative campaigns for iconic companies and brands. About...
-
Transformation Director
3 days ago
Chicago, Illinois, United States ADM Full timeJob Summary:The Global Business Services Transformation Director is a key leadership role within ADM's Global Business Services (GBS) team. This position is responsible for developing and implementing strategic initiatives to drive productivity and efficiency across the enterprise.Key Responsibilities:Leverage external benchmarks and collaborate with Global...
-
Regulatory Affairs Expert
3 days ago
Chicago, Illinois, United States Northern Trust Full timeAbout Northern TrustNorthern Trust is a leading global financial institution with a rich history dating back to 1889. As a Fortune 500 company, we have established ourselves as a trusted partner for individuals, families, and institutions seeking innovative financial services and guidance.Our commitment to service, expertise, and integrity has enabled us to...
-
Regulatory Compliance Specialist
14 hours ago
Chicago, Illinois, United States Daubert Chemical Co. Inc. Full timeJob DescriptionDaubert Chemical Co. Inc. is a leading specialty chemical manufacturer seeking a highly skilled Regulatory Compliance Specialist to ensure global compliance with regulations and standards. The ideal candidate will have a strong background in regulatory affairs and a proven track record of ensuring compliance with international, national, and...
-
Global Director Talent Acquisition
3 weeks ago
Chicago, Illinois, United States UL Solutions Full timeJOB DESCRIPTIONReporting to the VP of Talent & UL University, this role is responsible for the Global Talent Acquisition strategy, improving the performance of the talent acquisition function globally with the right operating model and deploying world-class talent acquisition programs. Programing is to be grounded in strategic workforce planning and deliver...
-
Technical Regulatory Specialist
3 months ago
Chicago, Illinois, United States Northern Trust Full timeAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
-
Senior Director of Global Pricing Strategy
1 week ago
Chicago, Illinois, United States TransUnion Full timeAbout the RoleWe are seeking a highly experienced and strategic leader to join our team as Senior Director of Global Pricing Strategy. As a key member of our Global Solutions division, you will be responsible for developing and implementing innovative pricing strategies that drive revenue growth and improve price realization across our organization.Key...
-
Chicago, Illinois, United States McDonald's Global Technology Full timeJob DescriptionCompany Description:McDonald's evolving Accelerating the Arches growth strategy puts our customers and people first and demonstrates our competitive advantages to strengthen our brand. We are recognized on lists like Fortune's Most Admired Companies and Fast Company's Most Innovative Companies.Doubling Down on the 4Ds (Delivery, Digital, Drive...
-
Chicago, Illinois, United States Northern Trust Full timeAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
-
Head of Global Policy
2 weeks ago
Chicago, Illinois, United States Epic Games Full timeWHAT DEFINES EPIC? At the heart of Epic's achievements are skilled and dedicated individuals. Epic is committed to fostering a collaborative, inclusive, and innovative atmosphere. Whether it’s developing award-winning games or creating engine technology that empowers others to produce visually captivating interactive experiences, we are always pushing the...
-
Senior Director of Global Pricing Strategy
1 week ago
Chicago, Illinois, United States TransUnion Full timeAbout the RoleWe are seeking a highly experienced and strategic leader to join our team as Senior Director of Global Pricing Strategy. As a key member of our Global Solutions division, you will be responsible for developing and implementing innovative pricing strategies that drive revenue growth and improve price realization across our organization.Key...
