- This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director), in the development & execution of the regulatory strategy. Area of responsibility has significant regulatory impact and possibly significant impact to ABBV overall.
- Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.
- May also serves as primary liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
- Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
- Operates independently, with recognition of when to consult management.
- Makes decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction.
- Assists in the development, training, and mentoring of staff members.
- Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
- Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
- Demonstrates solid understanding of current US and Canada regulations and guidance, political and legal climate, and industry practices to assist in meeting organizational goals.
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory.
- Presents pertinent regulatory information to appropriate cross-functional areas.
- Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
- Required Education: Bachelor's Degree (pharmacy, biology, pharmacology) or related life sciences.
- Preferred Education: Relevant advanced degree is preferred. Certification a plus.
- Required Experience: 8 years Regulatory, R&D or Industry-related experience.
- Preferred Experience: 5 years in pharmaceutical regulatory affairs.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
- Extensive experience interfacing with government Agencies and Health Authority personnel.
- Able to deliver challenging messages effectively without compromising important business relationships.
- 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.
- Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus.
-
AbbVie North Chicago, United States Full timeJob Description · The Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in developmen ...
-
Regulatory Affairs Associate
2 days ago
Validation Associates North Chicago, United States**Description**: · **Accountability / Scope**: · - As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · - Individual shall develop partne ...
-
Regulatory Affairs Associate
3 days ago
Validation Associates North Chicago, United States**Description**: · **Accountability / Scope**: · - As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. · - Individual shall develop partne ...
-
Director, Cmc Product Development
1 week ago
AbbVie North Chicago, United States**Company Description** · Manages multiple projects and contributes to project prioritization. Represents AbbVie on high profile partnerships and collaborations with other pharma/biotech companies and at the Joint Development Committee level driving joint decisions for the develo ...
-
Regulatory Risk Managment Specialist
1 week ago
Northern Trust Corp. Chicago, United StatesAbout 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 succe ...
-
National Field Director, Gi Care/hcv
2 days ago
AbbVie North Chicago, United States**Company Description** · Purpose: · The US Field Medical Lead will establish the strategy and provide oversight and direction for GI Care and HCV therapeutic US Field Medical Team, including accountability for attainment of US medical and business objectives in these therapeutic ...
-
Program Associate
2 days ago
Northern Trust Corp. Chicago, United StatesAbout 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 succe ...
-
Director of Safety
6 days ago
fairlife Chicago, United Statesfairlife, LLC is a Chicago-based nutrition company that creates great-tasting, nutrition-rich and dairy products to nourish consumers. · With nearly $2B in annual retail sales, fairlife's portfolio of delicious, lactose-free, real dairy products includes**:fairlife ultra-filtered ...
-
Compliance Analyst
1 day ago
IMC Financial Markets Chicago, United StatesThe Compliance Team is seeking a qualified individual to drive IMC's regulatory vision by promoting new regulatory developments and best practices, as well as adhering to compliance requirements. · Your Core Responsibilities: · - Monitor daily trading activity using the IMC's in- ...
-
Managing Director- Enterprise Compliance Testing
18 hours ago
BMO US Chicago, United States320 S Canal Street Chicago Illinois,60606 · The Managing Director - Enterprise Compliance Testing (MD) leads and directs the second line compliance testing function, with an enterprise mandate for BMO Financial Group across all jurisdictions and legal entities that BMO operates. ...
-
Corporate Counsel, Transactions
2 days ago
Green Thumb Chicago, United States**The Role** · **Responsibilities** · - Manage, with the supervision of the Assistant General Counsel, transactions from start to finish, including drafting NDAs and term sheets, organizing and managing the due diligence and closing processes, drafting definitive transaction docu ...
-
Program Manager, Regulatory, Mobility
1 day ago
Uber Chicago, United States**About the Role** · We are currently looking for a Program Manager for our Regulatory, Mobility Legal team. We are seeking specific expertise in supporting a fast-paced organization through the development, implementation, and management of regulatory strategy and programs to en ...
-
AbbVie North Chicago, United States**Company Description** · The Executive Medical Director is responsible for the safety strategy for solid tumors late-stage oncology portfolio, and to supervise, manage and mentor the safety physicians (Group MDs, Senior MDs and medical directors) and the MSE staff supporting the ...
-
Regulatory Risk
1 week ago
Northern Trust Corp. Chicago, United StatesAbout 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 succe ...
-
Medical Liaison
1 week ago
Novo Nordisk Chicago, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
-
Compliance Manager
18 hours ago
Elevance Health Chicago, United StatesJob Family: FRD > Compliance · - Type: Full time · - Date Posted: Apr 18, 2024 · - Anticipated End Date: May 17, 2024 · - Reference: JR112645 · **Description**: · **Compliance Manager** · **Location: 8600 W Bryn Mawr Ave. Chicago, IL.** · This position will take part in Elevance ...
-
Invenergy Chicago, United StatesInvenergy 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 ...
-
BMO US Chicago, United States320 S Canal Street Chicago Illinois,60606 · Supports the business/group leader in the effective implementation, maintenance and administration of first line of defense (1st LOD) programs (e.g., operational risk, AML, compliance, regulatory, etc.), including overseeing business op ...
-
Small Business Administration
1 week ago
BMO US Chicago, United States4531 N Broadway Chicago Illinois,60640 · Provides Small Business Administration (SBA) lending expertise for an assigned territory to create an effective internal and external network for successful Commercial Banking / Emerging Middle Market (EMM) client acquisition opportunities ...
-
Vp of Human Resources
3 days ago
Hueman PE Talent Solutions Chicago, United States**Point C Health is hiring a VP of Human Resources for a full-time position in Chicago, IL.** · **The position is local-remote, and you must be able to attend monthly meetings on-site.** · Point C is a third-party administration platform for medical and dental benefits for self-i ...
Associate Director, RA Global Regulatory Strategy, US - North Chicago, United States - AbbVie
Description
Job Description
Job DescriptionCompany 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 Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionThe Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements. This individual assures that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs.
Responsibilities:
Significant Work Activities -Keyboard use (greater or equal to 50% of the workday)
QualificationsAbbVie 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.