What are the responsibilities and job description for the Regulatory Affairs Associate Director position at Collabera?
Job Title: Regulatory Affairs Associate Director/Director (Oncology)
- We are seeking an experienced Regulatory Affairs Associate Director/Director to join our growing team. As the Global Regulatory Lead, you will develop and implement global regulatory strategies for early-stage oncology assets within a dynamic, biotech-like environment in a well-established pharmaceutical company. You will provide leadership on cross-functional teams, guide regulatory strategy, and manage interactions with global health authorities.
Key Responsibilities:
- Lead global regulatory strategy for oncology projects, including clinical, nonclinical, and CMC aspects.
- Advise project teams on regulatory requirements and strategy risks.
- Collaborate with global regulatory affiliates and lead Health Authority meetings.
- Oversee the preparation and submission of regulatory documents (INDs, CTAs, amendments).
- Ensure consistency and adherence to standards for regulatory submissions.
- Manage non-program-specific projects such as department initiatives and assessments.
Qualifications:
- Bachelor's degree in life sciences or related field; advanced degree preferred.
- 5–7 years (Assoc. Dir)/7–9 years (Director) of regulatory experience in oncology drug development.
- Expertise in global regulatory requirements and guidelines.
- Strong leadership, communication, and collaboration skills.
Pay range:
$80/hr - $85/hr.
Work Schedule:
Hybrid - 3 onsite/2 remote
Salary : $80 - $85
