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Global Regulatory Lead, Oncology, Global Regulatory Strategy & Policy

Remote:

Full Remote

Contract:

Freelance

Salary:

86 - 106K yearly

Experience:

Senior (5-10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Ph.D., M.D., PharmD., MS or equivalent experience, 3-5 years significant experience in regulatory affairs, Expert understanding of U.S. FDA regulations, Direct experience in developing regulatory strategy for Oncology, Strong ability to work in a matrix environment.

Key responsabilities:

Develop global regulatory strategy for Oncology products
Lead regulatory submissions and ensure quality controls
Write and review regulatory documents like INDs and BLAs
Foster relationships with FDA and key stakeholders
Interpret changes in the regulatory environment

VARITE INC Information Technology & Services Large https://www.varite.com/

1001 - 5000 Employees

See more VARITE INC offers

Job description

Pay rate range: $45-55/hr.

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., 3-5 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.