Regulatory Project Manager
Company: IT Trailblazers, LLC
Location: San Mateo
Posted on: November 22, 2021
Hi,I hope you are doing well.We have the below position with
global pharma our client and it's a long-term contract as well.
Please review the description and let us know your thoughts!Role:
Regulatory Project Manager Location: Foster City, CADuration: Long
Term Contract Specific Responsibilities and skills for Position The
Manager in Regulatory Project Management will be 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. Essential Duties and Job Functions
- 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 the
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.The Manager in Regulatory Project
Management is 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
- The Manager in Regulatory Project Management 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).Knowledge,
Experience, and Skills
- Excellent verbal, written, negotiation, and interpersonal
communication skills are required. Excellent organizational skills
and the ability to work on a number of projects with tight
timelines are required.
- 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.
- 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. - provided by Dice
Keywords: IT Trailblazers, LLC, San Mateo , Regulatory Project Manager, Executive , San Mateo, California
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