2 Manager in Regulatory Project Management Jobs in San Mateo, CA
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Manager in Regulatory Project Management
$143k-187k (estimate)
Full Time | Business Services
2 Weeks Ago
Fladger Associates is Hiring a Manager in Regulatory Project Management Near San Mateo, CA
Foster City, CA or Morris Plains, NJ, but open to remote
Contract Duration: 9-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities
Contract Duration: 9-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities
- Excellent employment opportunity for a Manager in Regulatory Project Management in the Foster City, CA or Morris Plains, NJ.
- Strongly Prefer Foster City, CA or Morris Plains, NJ, but open to remote candidates.
- Subject to Vaccine Mandate
- Responsible for the coordination, prioritization and tracking of regulatory activities and submissions associated with the company's research, development and post-marketing activities for a variety of therapeutic areas.
- Regulatory activities may include support for both products in early and late-stage development and marketed products.
- Under the direction of a Senior Regulatory Project Manager the Manager in Regulatory Project Management will develop and maintain detailed timelines for regional and cross-regional regulatory activities and submissions for assigned therapeutic areas in US, EU, CAN, and ensure planning and coordination of activities via the Regulatory Submission Team.
- The Manager in Regulatory Project Management will foster effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Regulatory Project Team.
- Responsible for ensuring regulatory submissions are prepared according to defined Corporate or Regulatory timelines
- Working with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
- Tracking regulatory commitments and timelines for maintenance activities such as Post-marketing Commitments and Follow-up Measures, and ensuring appropriate submissions are made in accordance with applicable requirements and deadlines.
- Strategic lead of cross-regional submissions.
- Influence within RPM team
- May initiate or contribute to local improvements within Regulatory Project Management which have a significant impact on the business and work collaboratively with other functional areas and Regulatory Affairs' functions at other sites (including the UK and Canada).
- Five to seven years of relevant experience are required; ideally experience in both Regulatory Affairs and Project Management is sought, and a BA Degree in a relevant discipline. An advanced degree is desirable.
- The Manager in Regulatory Project Management will ideally have a modest knowledge of regulatory requirements specific to key regions such as the US and EU and have a general awareness of current global and regional trends in Regulatory Affairs.
- Excellent verbal, written, negotiation and interpersonal communication skills are required.
- Excellent organizational skills and ability to work on a number of projects with tight timelines is required.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$143k-187k (estimate)
POST DATE
06/06/2024
EXPIRATION DATE
07/02/2024
WEBSITE
fladgerassociates.com
HEADQUARTERS
Bear, DE
SIZE
<25
INDUSTRY
Business Services
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