Job Title:
Senior Manager, Regulatory Affairs – Oncology
Type of company:
Innovative biotech organisation operating within the oncology space, focused on advancing cutting-edge therapeutic products across global markets.
Package:
$160-180,000 + bonus + equity + comprehensive benefits package.
Everything you need to know about the role:
This is a fully remote opportunity (East Coast US-based) for an experienced Regulatory Affairs professional with a strong background in oncology, ideally within a Phase II Biotech.
You’ll play a key role in supporting global regulatory strategy and execution, working closely with senior leadership to ensure compliance across both US and international markets.
The role offers broad exposure across regulatory activities, including submissions, agency interactions, and cross-functional collaboration within a fast-paced and innovative environment.
You will:
- Support regulatory strategy and ensure compliance with global regulatory standards
- Prepare and contribute to regulatory submissions (e.g. INDs, BLAs, amendments, expedited programs)
- Coordinate and deliver high-quality regulatory documentation within defined timelines
- Review submission packages for compliance with international regulations
- Write, edit, and maintain technical regulatory documents and SOPs
- Ensure accurate maintenance of regulatory documentation systems
- Liaise with regulatory authorities as required
- Collaborate cross-functionally to support product development and registration activities
Experience and qualities that make you a strong fit:
- Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s preferred)
- 5+ years’ experience in Regulatory Affairs within pharma, biotech, or CRO
- Strong understanding of global regulatory frameworks and submission processes
- Experience contributing to IND modules (M1/M2), amendments, and agency responses
- Ability to interpret regulations and translate them into actionable plans
- Excellent organisational and project management skills
- Strong communication skills with the ability to influence cross-functional teams
- High attention to detail with strong analytical and problem-solving capabilities
- Comfortable working in a fast-paced, remote environment managing multiple priorities
Preferred:
- Advanced degree in a relevant scientific discipline
- Broader exposure to global regulatory submissions beyond the US
- Experience within innovative or emerging biotech environments
What’s on offer:
- Fully remote working environment
- Opportunity to work on innovative oncology products
- Exposure to global regulatory strategy and submissions
- Collaborative and high-performing team culture
- Competitive compensation package including bonus and equity
- Career development within a growing organisation
Could this be the role for you?
If you’re an experienced Regulatory Affairs professional with experience with INDs/BLAs, looking for a strategic and hands-on role in a dynamic biotech environment, this could be an excellent next step.