Senior Manager, Regulatory Affairs CMC (Hybrid)
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Job Location:
South San Francisco, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
The Senior Manager Regulatory Affairs Chemistry Manufacturing and Controls (CMC) works with internal stakeholders and external partners to deliver products to patients. This individual prepares CMC regulatory strategies that enable first pass approvals. The Senior Manager develops and manages the content strategy for regulatory submissions which include INDs CTAs amendments new marketing applications and supplements or variations. They build and maintain relationships within the Regulatory Affairs functional areas as well as Operations and Research & Development (R&D) organizations. The Senior Manager represents CMC on teams such as product development Global Regulatory Product Teams and Operations brand teams where they negotiate influence and provide strategic advice.
Responsibilities:
- Prepares CMC regulatory product strategies.
- Prepares manages reviews and revises regulatory submissions including new applications amendments renewals annual reports supplements and variations ensuring data and strategy are effectively presented to regulatory agencies and compliance is maintained.
- Responds to regulatory information and global regulatory information requests as required.
- Analyzes and interprets information that impacts regulatory decisions including manufacturing change requests and regulatory procedures and stays abreast of regulatory climate changes.
- Seeks expert advice and technical support for developing regulatory strategies and preparing submissions.
- Develops strategies for CMC agency meetings manages preparation and oversees the content of pre-meeting submissions.
- Manages products and change control according to applicable regulations and company policies and approves manufacturing change requests.
- Represents CMC regulatory affairs on cross-functional teams and project initiatives such as product development Global Regulatory Product Teams and Operations brand teams negotiating and influencing team members to maximize first pass approval chances.
- Develops implements and documents policies and procedures within the regulatory affairs department and participates in initiatives internal to Regulatory Affairs CMC.
- Analyzes legislation regulation and guidance and provides relevant analysis to the organization.
Qualifications :
Minimum Qualifications:
- Bachelors Degree in Pharmacy Chemistry Biology or Pharmacology Engineering or related subject.
- 8 years of pharmaceutical experience
- Experience developing and implementing successful global regulatory strategies.
- Experience working in a complex and matrix environment.
- Note: Higher education may compensate for years of experience
Preferred Qualifications:
- Relevant advanced degree preferred. Certification a plus.
- 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery R&D or Manufacturing.
Other Required Skills:
- Strong oral and written communication skills.
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 postingbased 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 orless 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 long-term 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 commissionincentive 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 paidand 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 :
Full-time
Key Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
