Senior Manager RA, Global Regulatory Strategy
Company: Disability Solutions
Location: Pleasanton
Posted on: March 15, 2023
Job Description:
The Sr. Manager Regulatory Affairs represents US Regulatory
Affairs for pharmaceutical development projects and marketed
products. Working with manager, responsible for development and
communication of global regulatory strategy on R&D project
teams.Ensures technical accuracy and regulatory compliance of all
submissions for which they are responsible and ensures that
applications are executed appropriately and submitted on time. Has
authority to make decisions on US regulatory strategy and to submit
complex submissions.Directs communications and interactions with US
FDA and other regulatory agencies as needed. Acts as primary
contact for the US FDA. Supports management with development of,
and as appropriate, leads implementation of department strategies
and policies.Responsibilities:
- Represent Department at Global Project Team. Develop US
regulatory strategic plan and provides guidance to GRL and project
team. Represent US Regulatory on Global Regulatory Teams for
assigned development projects and marketed products. Work with
GRL/manager to resolve complex project issues. Utilize US
regulatory expertise and knowledge of regulatory requirements and
regulations to strategically interpret, plan, and communicate
requirements to ensure governmental approvals are obtained
- Work with manager, set strategy for submissions of product
registration documents to health authorities worldwide. Interact
with other line functions in the preparation, review, and
completion of documents for regulatory submissions. Will be
responsible for US submissions (strategy and submission
preparation).
- Will clearly articulate US regulatory strategy at Project and
Regulatory Team meetings. Be able to negotiate with team to assure
acceptance of regulatory strategy. Assures compliance with project
team timelines and milestones.
- Will clearly articulate US regulatory strategy at Project and
Regulatory Team meetings. Be able to negotiate with team to assure
acceptance of regulatory strategy. Assures compliance with project
team timelines and milestones.
- Provide interpretive analyses of complex regulatory guidance
documents, regulations, or directives that impact Allergan
Aesthetics' products and operations. Advise personnel in other
departments regarding their applicability and impact.
- Education equivalent to a PhD or MD degree or equivalent in a
scientific field or experience in lieu of, plus at least 4 years'
experience in Regulatory Affairs; or
- Education equivalent to a MS degree or equivalent in a
scientific field or experience in lieu of, plus at least 6 years'
experience in Regulatory Affairs; or
- Education equivalent to a BS degree or equivalent in a
scientific field or experience in lieu of, plus at least 8 years'
experience in Regulatory Affairs;
- Analytical thinking and problem-solving skills
- Excellent communication skills, verbal and written.
- Excellent interpersonal skills and leadership potential.
- Computer literate with knowledge of EDMS systems for electronic
storage and submission.
- Advanced knowledge of US and ICH regulations
- Excellent negotiation skillsApplicable to California Applicants
Only
- The below range is the range that we in good faith believe is
the range of possible compensation for this role at the time of
this posting. We may ultimately pay more or less than the posted
range and this range is only applicable for jobs to be performed in
California. This range may be modified in the future.
- The salary range for this role is posted below
- This job is eligible to participate in our short-term incentive
program
- This job is eligible to participate in our long-term incentive
programs
- We offer a comprehensive package of benefits including paid
time off (vacation, holidays, sick), medical/dental/vision
insurance and 401(k) to eligible employees.
- 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 Company's sole
discretion unless and until paid and may be modified at the
Company's sole discretion, consistent with the law.AbbVie is an
equal opportunity employer including disability/vets. It is
AbbVie's 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 disabled veteran,
recently separated veteran, Armed Forces service medal veteran or
active duty wartime or campaign badge veteran or a person's
relationship or association with a protected veteran, including
spouses and other family members, or any other protected group
status. We will take affirmative action to employ and advance in
employment qualified minorities, women, individuals with a
disability, disabled veterans, recently separated veterans, Armed
Forces service medal veterans or active-duty wartime or campaign
badge veterans. The Affirmative Action Plan is available for
viewing in the Human Resources office during regular business
hours.Significant Work Activities: N/ATravel: NoJob Type:
ExperiencedSchedule: Full-timeCompensationMinimum Salary $110,500
Maximum Salary $216,000
Keywords: Disability Solutions, Pleasanton , Senior Manager RA, Global Regulatory Strategy, Executive , Pleasanton, California
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