This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies. They are seeking a Regulatory Affairs Associate Director who can contribute to Ex-US regulatory strategies and regulatory submissions. Reporting into the Regulatory Affairs Senior Director, you will interact with global regulatory authorities including EMA, Health Canada, MHRA, Swiss Medic and TGA. This company offers innovative science, a patient-focused company culture, and the ability to work remotely. With their first commercial launch expected this year, now is an exciting time to join this innovative organization!
- Collaborate closely with functional leaders to create the optimal regulatory strategies for tumor infiltrating lymphocyte (TIL) product candidates in Europe, Canada, and other parts of the world.
- Negotiate optimal development paths within cross-functional teams and with EMA and other Health Authorities.
- Execute clinical-regulatory development plans on-time and while managing all identified risks.Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments.
- Ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
- Lead cross-functional teams in developing strategic briefing packages and in preparing for health authority meetings or interactions.
- Ensure that evolving global regulations, guidelines, and health authority expectations (especially those related to biologics or ATMPs such as cell therapy products) are incorporated into program decision making.
- Work within the Regulatory department and with other functional areas on process improvements.
- Must adhere to company’s core values, policies, procedures, and business ethics.
- Perform miscellaneous duties as assigned.
- Bachelors in a scientific discipline required. Advanced degree (MS, PhD, Pharm D) preferred.
- Minimum 7 years’ experience in Regulatory Affairs for pharmaceutical drugs and biologics.
- Must have late‑stage Regulatory experience in oncology drug development.
- Must have experience in creating and negotiating the clinical-regulatory aspects of oncology programs with EMA. Experience with other Ex-US Health Authorities (Health Canada, MHRA, TGA, etc.) a plus.
- Experience in the creation, submission, and negotiation of Ex-US Market Applications (MAA, NDS, etc) required.
- Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents including briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries.
- Ability to write clearly and concisely, within agreed timelines.
- Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences.
- High attention to detail and accuracy.
- Strong organizational and planning skills.
- Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
- Excellent interpersonal, verbal, and written communication skills
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Must be comfortable with ambiguity within an evolving company.
The budgeted salary range for this position is US$175,000 to $195,000+ plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration. This is a remote position.