Manager Regulatory Affairs (Oncology)

Manager, Regulatory Affairs (Oncology)

We're currently seeking a dynamic Manager in Regulatory Affairs to join a great organization and play

a pivotal role in providing strategic Regulatory management and direction to projects and products.

Reporting to the Director, of Regulatory Affairs, you'll collaborate closely with the Global Regulatory

Lead in driving the mission forward.

Key Responsibilities:

* Strategic Regulatory Management: Oversee planning and execution of Regulatory activities

for both early and late phase development. Lead Regulatory submissions and associated

activities for IND, CTA, BLA.

* Timely Compliance: Ensure timely completion and support of submission of periodic

Regulatory reports, including integration into applicable annual reports.

* Team Integration: Represent Regulatory Affairs within various project teams and product

development teams, ensuring seamless collaboration.

* Regulatory Expertise: Provide expert guidance in writing and reviewing all sections of

Regulatory applications and submissions, ensuring successful filings and compliance with

requirements.

* Regulatory Landscape: Monitor the impact of changing regulations on submission strategies

and provide informed advice to internal stakeholders.

* Strategic Alignment: Ensure company strategy is clearly articulated in Regulatory documents

and submissions, aligning with organizational goals.

* Objective Setting: Develop personal and project objectives that provide support for overall

business goals, fostering growth and progress.

* Standardization: Define team operating standards and ensure adherence to essential

procedures.

Job Requirements:

* Education: Bachelor of Science (or equivalent degree) in a scientific discipline.

* Regulatory Expertise: Proven experience in all facets of Regulatory Affairs, including a strong

working knowledge of the drug development process and FDA requirements for INDs,

BLAs/NDAs.

* Compliance and Standards: Ability to analyze and resolve problems in accordance with SOPs,

the CFR and Guidelines, cGMPs, cGLPs, and cGCPs.

* Communication and Leadership: Strong oral and written communication skills, effective time

management, and a team-oriented leadership approach.

Prior experience in oncology is highly desirable.