Senior Manager, Global Regulatory Strategy

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Job 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 . on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description
The Sr Manager Regulatory Affairs represents regulatory affairs for device development and/or marketed product projects. Responsible for development, communication, and execution of regulatory strategic plans to Global Regulatory Lead (GRL) and project team. Plans and prepares (or oversees) complex regulatory submission documents primarily for US/EU regulatory filings, ensures technical accuracy, and regulatory compliance. Ensures that applications are executed appropriately and submitted on time.

Directs communication and interactions with US FDA/Notified Bodies, as primary contact for the related projects. Utilizing detailed, in-depth understanding of regulations for device products, leads, and participates in global regulatory product teams, interprets regulations, and provides regulatory guidance.Supports management with implementation of departmental strategies and policies.

Duties and Responsibilities:

• Represents US/EU Regulatory in project teams. Develops US/EU regulatory filing strategy, with minimal supervision. Provides regulatory strategy and guidance to global product owner/project team in line with commercial objectives.
• Works collaboratively with GRL/regulatory/cross functional team to resolve complex project issues.
• Utilize US/EU device regulatory expertise and extensive knowledge of requirements to strategically interpret, plan, and communicate with the team.
• Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.
• Ensures planned device development activities comply with US/EU regulatory guidelines, and, in cases where they do not, provide a critical analysis of the risks and issues.
• Plans and prepares (or oversees) complex regulatory documents for US (PMA, PMA supplements and annual reports, IDE, IDE supplements and annual reports, FDA meetings), EU (various), and potentially OUS submissions, under minimal supervision.
• Prepares clear, complete, and accurate documents that are logically constructed and comprehensive in content and on time.
• Reviews labeling and packaging components for new products/indication extensions to ensure accuracy and compliance with regulations and aligned with the commercial needs. Similarly ensures continued compliance with new/modified requirements for marketed products.
• Communicates planned/approved changes with operations, commercial, medical affairs, marketing, and other cross-functional partners.
• Effectively plan, organize, and conduct formal meetings with regulatory agencies. Be able to negotiate to ensure acceptance of appropriate regulatory strategy. Assures compliance with project team timelines and milestones.
• Maintains professional relationships with functional areas outside regulatory.
• Develops professional relationships with Health Authorities through supervised process.
• Establishes relationships with direct colleagues as well as global regulatory team to ensure local RA activities are in line with global business priorities.
• Assists in training and mentoring of personnel, performs peer review of documents, and may supervise as appropriate.
• Acts as a Person Responsible for Regulatory Compliance for the EC Authorized Representative or support site audits as needed.
• Fosters a dynamic working environment by appropriately challenging processes, inspiring a shared vision, enabling others to act, leading by example, and encouraging intra- and inter-departmental team members to meet and/or exceed expectations.

Qualifications
Education and Experience Guidelines

• Education equivalent to a BS degree in a scientific field, plus 8 years experience in regulatory affairs; or
• Education equivalent to a MS degree in a scientific field, plus 6 years experience in regulatory affairs;or
• Education equivalent to a PhD degree in a scientific field, plus 4 years experience in regulatory affairs.
• Experience in US medical devices regulatory affairs is necessary.
• Demonstrated experience of submissions to FDA as a primary contact and lead meetings with FDA.

Essential Skills and Abilities

• Analytical thinking and problem-solving skills and ability to follow-through.
• Excellent communications skills, written and verbal.
• Excellent interpersonal and negotiation skills and leadership potential.
• Ability to work well independently and with others.
• Excellent organizational skills and attention to detail.
• Ability to handle multiple projects simultaneously and maintain flexibility.
• Computer literate with excellent knowledge of systems for electronic storage and submission. Experience with Adobe Acrobat, MS Excel, MS PowerPoint, and MS Word, and ability to learn new computer programs.
• Ability to understand and use technical documents, such as regulations and guidance documents, as well as technical reports, in support of regulatory submissions.
• Advanced knowledge of US/EU medical device regulations.
• Ability to function in a controlled environment regulated by FDA QSRs/ISO 13485 (or other regulations/standards as required for site/project) and to handle confidential data.
• Ability to meet deadlines; take initiative and make decisions within department/company guidelines.

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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