Description:
True Job Title: Manager in Regulatory Project Management
Location: Strongly Prefer Foster, CA or Morris Plains, NJ, but open to remote candidates
Duration: 12 Months
*Subject to Vaccine Mandate*
The Manager in Regulatory Project Management will be responsible for the coordination, prioritization and tracking of regulatory activities and submissions associated with the companys 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 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 Postmarketing 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 ability to work on a number of projects with tight timelines is 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.