OperationsProject Management - Project Manager - General II
OperationsProject Management - Project Manager - General II
Posted on :
13-10-2024
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Job Description
Job Description: Job Title : Global Regulatory Lead Oncology Global Regulatory Strategy & Policy
Location: Remote
Duration: 6 months
Bill Rate: BR5 to BR/hr (Can submit profiles on higher rate also)
Mandatory Requirement: Need minimum 15 years of experience in Oncology
Position Summary / Objective
Develop global regulatory strategy for Oncology products in development and through life cycle management taking into account all relevant guidance commercial needs and company objectives.
The Engagement Manager is located at Princeton Pike (PPK) so ideally the candidate is local and can work a hybrid scheduled onsite at PPK. However the Engagement Manager will also consider candidates who are 100% remote in the US.
Responsibilities
Develop global or US regulatory strategy for Oncology products in development and through life cycle management considering all relevant guidance commercial needs and company objectives.
Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities
Lead regulatory dossier submissions to global and/or FDA (IND BLA NDA and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions
Writing regulatory documents (e.g. new INDs briefing book content BT Designation request Priority Review Requests ODD); reviewing core documents to support IND/BLA/NDA in conjunction with EUL or GRL as needed
Provide strategic direction (and content input) on US Labeling
Anticipate and interpret key trends and changes in the global/US regulatory environment and provide strategic guidance regarding development plans as a result.
Foster positive relationships with FDA.
Build and maintain a strong collaborative relationship with all key stakeholders including Commercial Medical Affairs Promotion & Compliance Global Development and other functions key to the success of product development.
Interact routinely and will develop a strong team environment with colleagues throughout GRS
Education Requirements
Ph.D. M.D. PharmD. MS or commensurate experience
Experience Requirements:
Significant experience in regulatory affairs (e.g. 35 years)
Key Competency Required:
Expert understanding of policy laws regulations and guidelines as they apply to U.S. FDA for drug development and approval.
Expert understanding of drug development process and understanding of scientific content and complexities related to a project in Oncology.
Direct experience in developing strategy and leading teams through interactions with FDA.
Extensive experience in initiating and conducting successful interactions within FDA.
Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals
Other Qualifications:
Strong team player using both internal and external resources to execute regulatory activities and working across organizational functional and geographic boundaries to achieve company goals.
Communicates opinions facts and thoughts with clarity transparency and honesty
Demonstrates ownership of results within (and beyond) area of responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
Looks for opportunities for continuous improvement.
Additional Sills:
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Required
Importance
Experience
Employment Type
Full Time
Key Skills
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