What are the responsibilities and job description for the Director of Regulatory Affairs position at Medella Life?
A clinical-stage oncology biotech is seeking a Director of Regulatory Affairs to lead global regulatory strategy across its pipeline.
This is a hands-on leadership role within a lean, high-growth environment, offering direct interaction with executive leadership and the opportunity to shape regulatory direction across multiple programs.
Key Responsibilities:
- Lead global regulatory strategy for oncology assets (early–mid stage, with progression toward registrational development)
- Assist in authoring and oversee INDs, IND amendments, and briefing documents (including support for future NDA/BLA submissions)
- Liaison with the FDA, leading key interactions
- Provide regulatory guidance on clinical development, including study design, endpoints, and overall strategy
- Partner cross-functionally with Clinical, CMC, and other teams to ensure aligned regulatory execution
- Establish and refine regulatory processes and infrastructure appropriate for a scaling biotech
- Mentor junior team members and contribute to the growth of the RA function
Requirements:
- 10–15 years of Regulatory Affairs experience within biotech/pharma, with a strong focus in oncology or rare disease
- Proven experience leading IND submissions and managing FDA interactions independently
- Exposure to NDA/BLA submissions strongly preferred
- Deep understanding of US regulatory frameworks; global experience (EMA/ICH) a plus
- Experience working in small to mid-sized biotech environments
- Ability to operate both strategically and hands-on in a fast-paced setting
- Strong communication and cross-functional leadership skills
Preferred Qualifications:
- Advanced degree (PhD, PharmD, or MSc) in a life sciences discipline
- Prior experience supporting or leading registrational strategy for oncology products
- Experience with accelerated/expedited approval pathways in the US
- Background in both solid tumours and haematologic malignancies
- Previous involvement in advisory committee preparations or regulatory inspections
- Experience building or scaling a Regulatory Affairs function in an emerging biotech