Regulatory Affairs Strategy Lead (Associate Director)

HireMinds; Massachusetts; Remote; USD 120,000 - 160,000; Full time

Job summary

A small to mid-size pharmaceutical client is seeking a Regulatory Affairs Strategy Lead (Associate Director) to join their team remotely. The role involves overseeing clinical trial applications, developing regulatory strategies for oncology and rare diseases, and ensuring compliance with regulations. Candidates should have significant experience in regulatory affairs, particularly with INDs and interactions with regulatory bodies such as the FDA.

Qualifications

• 6+ years of experience in pharmaceutical regulatory affairs.
• Experience with INDs, NDAs, and global regulatory submissions.
• Advanced knowledge of oncology drug development regulations.

Responsibilities

• Lead the regulatory strategy for oncology and rare disease programs.
• Monitor regulatory changes affecting asset development.
• Manage project teams to meet deadlines effectively.

Skills

Regulatory strategy development

Regulatory compliance

Project management

Cross-functional collaboration

Education

B.S/M.S. in relevant field

Job description

Our small to mid-size pharmaceutical client on the East Coast is looking to hire aRegulatory Affairs Strategy Lead (Associate Director)(REMOTE) to their team! They have an exciting small molecule pipeline of both early and late-stage oncology and rare disease programs! This role will act as a Regulatory Affairs Program Lead and be responsible for the oversight of clinical trial investigational new drug applications (INDs), clinical trial applications (CTAs) and marketing applications. In addition will finalize regulatory submission documents and regulatory submission. Other responsibilities include but not limited to:

• Develop regulatory strategies for rare disease and/or oncology programs
• Provide solid regulatory solutions and guidance to the cross-functional teams and senior management
• Monitor global regulatory changes that may impact asset development
• Provide tactical support and operational expertise with hands-on support as needed
• Ensure compliance of regulatory strategies and submissions
• Assess project plans and timelines; manage project teams effectively and collaboratively to ensure all projects are appropriately prioritized and key goals are met on time
• Contribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company

Requirements:

• B.S/M.S. and 6+ years of work experience in pharmaceutical regulatory affairs
• 5+ years of regulatory experience working with global development and submission plans
• Global regulatory affairs experience working with both the US and EU
• Working with small molecule programs/assets
• Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU
• Must have experience filing INDs and/or NDAs and engagement with FDA and other regulatory bodies
• MUST be able to work East Coast business hours