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 at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
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.
Assures that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.
This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.
Responsibilities :
Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
Assigned matters may have a moderate impact on business activities and operations.
Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion 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.
Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
Assists in the development, training of staff members.
- Key contributor responsible for 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.
- Supports the regulatory submission and approval process. Broadly applies regulatory / technical knowledge of government regulations and skills across therapeutic areas.
- Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
- 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).
Qualifications
- Required Education : Bachelors degree (pharmacy, biology, chemistry, pharmacology) or industry related.
- Preferred Education : Advanced Degree or Certifications a plus
- Required Experience : 6 years Regulatory, R&D, or Industry-related experience.
- Preferred Experience : 2-3 years in pharmaceutical regulatory activities
- Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
- Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
- Able to deliver challenging messages effectively without compromising important business relationships.
- Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.
- Experience working in a complex and matrix environment.
- Global regulatory experience is a plus.
- Experience interfacing with government regulatory agencies.
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 https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :
https : / / www.abbvie.com / join-us / reasonable-accommodations.html
Manager, Global Regulatory Strategy US & Canada (Hybrid Onsite)
The Manager, Global Regulatory Strategy US & Canada 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. Responsible for a product(s) within a Therapeutic Area an...
Senior Manager Regulatory Strategy - Remote Opportunity
The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological products (developmental and marketed products); participates on global cross-functional teams ensuri...
Associate Director, RA Global Reg Strategy US & Canada (Onsite or Remote)
The Associate Director, RA Global Regulatory Strategy, US & Canada 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 t...
Senior Manager, Communication Corporate Affairs, Finance, Analytics & Corporate Strategy
Senior Manager, Communication Corporate Affairs, Finance, Analytics & Corporate Strategy. Foster open, honest, transparent communications between senior leaders, mid-level managers and non-exempt team members in ways that enhance engagement and service to customers. We are committed to equal emp...
Manager, Regulatory Strategic Planning (Hybrid Onsite)
Possesses proficient knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions; is able to provide business subject matter knowledge on assigned initiatives, and demonstrates effective problem solving & decision making, learning and adjust...
Senior Manager Regulatory Strategy - Remote Opportunity
The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation of regulatory strategies to ensure the successful US development and approval of assigned drug and biological products (developmental and marketed products); participates on global cross-functional teams ensuri...
Associate Director, Regulatory Strategic Planning (Onsite Hybrid)
Possesses extensive knowledge of the regulatory product lifecycle, business processes, and regulations across Regulatory sub-functions; is able to provide business subject matter knowledge on assigned initiatives, and demonstrates effective problem solving and decision making, learning and adju...
Senior Product Manager – Vulnerability Exposure Management - Secureworks - (Remote - USA East or Central time zone)
All employment decisions at Secureworks are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orient...
Manager, Regulatory Affairs
The Manager position in Regulatory Affairs contributes to the regulatory strategy for new and modified Sysmex medical device products. The Manager Regulatory Affairs is responsible for the preparation, documentation and submission of regulatory applications for Sysmex products. Maintain regulatory a...
Regulatory Affairs Manager
Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applicatio...