Senior Manager US Regulatory Strategy
Senior Manager US Regulatory Strategy
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Job Description
Description
The Sr Manager Regulatory Affairs represents US regulatory affairs for device development projects.
Responsible for development communication and of US regulatory strategic plans to Global Regulatory Lead (GRL) and project team.
Plans and prepares (or oversees) complex regulatory submission documents primarily for US regulatory filings ensures technical accuracy and regulatory compliance. Ensures that applications are executed appropriately and submitted on time.
Directs communication and interactions with FDA as primary contact for the related projects.
Utilizing detailed indepth 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 Regulatory in project teams. Develops US 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 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 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 IDE IDE supplements and annual reports FDA meetings) 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.
- Communicates planned/approved changes with operations commercial medical affairs and marketing.
- 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 US 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.
- Fosters a dynamic working environment by appropriately challenging processes inspiring a shared vision enabling others to act leading by example and encouraging intra and interdepartmental team members to meet and/or exceed expectations.
This position is based onsite in Irvine CA
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 problemsolving skills and ability to followthrough.
- 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 medical device regulations.
- Ability to function in a controlled environment regulated by FDA QSRs 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 or local law:
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 shortterm incentive programs.
This job is eligible to participate in our longterm incentive programs
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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
