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Senior Manager, Global Regulatory Strategy, US - Madison, United States - AbbVie
Description
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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job DescriptionSenior Manager, Global Regulatory Strategy, US & Canada, AbbVie Inc., Madison / Florham Park (Morris County) New Jersey
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.
Key Responsibilities
Ensure that regulatory strategies defined within the GRPT are effectively implemented and maintained in line with changing regulatory and business needs.
Identify and gather 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.
Responsible for product(s) with multiple driver indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director, or Director, in the development & execution of the regulatory strategy.
Serve 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.
Responsible for negotiations and decision-making for project related issues that have cross-functional impact.
Assist in the development, training of staff members.
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.
Support CMC sections of major, complex regulatory submissions, including Investigation New Drugs (INDs), Investigational Medicinal Product Dossier (IMPD), New Drug Applications (NDAs), Marketing Authorization applications (MAAs), Quality Overall Summaries (QOS), and Biologics License Applications (BLAs).
Work on projects for thoroughness, accuracy, and timeliness of CMC dossiers and responses by using electronic documentation management systems (EDMS).
Responsible for communicating and applying global regulations, including established or draft guidance, and review regulatory opportunities and risks.
Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
Recommend and implement changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidance, as well as corporate policies and management-related considerations.
Present pertinent regulatory information to appropriate cross-functional areas.
Operate in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).
QualificationsEducation & Experience
Bachelors degree or foreign academic equivalent in Pharmacy, Biology, Chemistry, Pharmacology or a related field of study, with four (4) years of regulatory R&D or industry-related experience in the following:
(i) supporting CMC sections of major, complex regulatory submissions, including Investigation New Drugs (INDs), Investigational Medicinal Product Dossier(IMPD), New Drug Applications (NDAs), Marketing Authorization applications (MAAs), Quality Overall Summaries (QOS), and Biologics License Applications (BLAs);
(ii) working on projects for thoroughness, accuracy, and timeliness of CMC dossiers and responses by using electronic documentation management systems (EDMS); and
(iii) communicating and applying global regulations, including established or draft guidance, and review regulatory opportunities and risks.
Pay Range: $146,944 - $208,000 per year
Apply online at . Refer to Req ID:
The compensation range listed above is the range of possible base pay compensation that AbbVie believes ingood faith that it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range may vary based on a number of factors, including geographic location. This range may also be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/visioninsurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
Additional InformationAbbVie 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.
