- 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.
- 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.
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Associate Director, Regulatory Affairs, US/Canada - 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)
Qualifications***Experience may determine level of position. Senior Manager or Associate Director.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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.
