Manager, Regulatory Affairs

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 X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description 1. Submissions, development and lifecycle maintenance Plans and prepares complex regulatory documents for US and ROW product approvals with minimum supervision. Resolves submission problem areas with team. Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision. Prepares complex expository and technical documents, logically constructed and comprehensive in content. Prepares documentation that is complete, accurate, and on time. Plans and implements regulatory activities that support lifecycle management. Reviews labeling and packaging components to ensure accuracy and compliance with government regulations. Submits product labeling in compliance with legal/regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. 2. Advisory Responsibilities Participates in global teams and provides regulatory strategy and guidance to global product development teams. Under minimal supervision develops US regulatory filing strategy. Provides regulatory strategy and guidance to global teams. Makes recommendations to shape the global strategy in line with regional/commercial objectives. Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness. Works collaboratively with cross-functional team to resolve project issues. Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements. Ensures planned device development activities comply with US and global regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues. Ensures that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration. 3. Communications and Business Support: Represents department on global project teams. Maintains professional relationships within the regulatory groups and with functional areas outside regulatory Conveys information on team timelines and status to supervisor Delivers presentations within the Company, as required Establishes relationships with US colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities 4. Mentoring Responsibilities: Performs peer review of complex regulatory documents. Provides leadership and development support to the Regulatory team. As appropriate, supervises and ensures training and development for Regulatory staff to ensure execution of all duties in a timely and efficient manner. 5. Process and Organizational Effectiveness Take personal responsibility for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects. Maintains a performance. Ensure roles and responsibilities for external services within a project are clearly defined and documented. Proactively resolve issues related to outsourced activities. Updates and maintains appropriate SOPs for the departments. Qualifications BS or BA in engineering, biology or other health sciences; plus five-year experience in regulatory affairs. At least three-year experience working in a medical device manufacturing company, preferably with capital medical equipment, highly desired. Knowledge of FDA QSR, ISO 13485 and other regulations/standards. Ability to focus on and achieve scheduled milestones, including contingency planning. Strong team-working and communications skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed. Competent using office software including MS Word, Excel, PowerPoint, and Outlook. ADDITIONAL REQUIREMENTS: Domestic travel up to 15%. 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