This commercial biotechnology company is focused on innovating, developing, and delivering tumor-infiltrating lymphocyte (TIL) therapies for patients with cancer. They are seeking a Regulatory Affairs Associate Director to lead one or more drug development programs, with specific emphasis on US and global regulatory strategy, regulatory submissions, and interaction with global regulatory authorities. Reporting into the SVP of Regulatory, this individual will work closely with functional leaders to create optimal pathways for approval for product candidates. This company offers innovative science, a collaborative and patient-centric company culture, and the ability to work remotely. With two approved products and an extensive pipeline of immuno-oncology programs, now is an exciting time to join this innovative organization!
Responsibilities:
- Collaborate closely with functional leaders to create the optimal regulatory strategies for tumor infiltrating lymphocyte (TIL) product candidates in the US, Europe, Canada, and/or other parts of the world.
- Help to negotiate optimal development paths within cross-functional teams and with health authorities.
- Execute clinical-regulatory development plans on-time and while managing all identified risks.
- Plan, manage, and create INDs, Clinical Trial Applications, Marketing 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.
- Works within the 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.
Qualifications:
- Bachelors in a scientific discipline required. Advanced degree (MS, PhD, Pharm D) preferred.
- Minimum 7 years’ experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Must have several years of Regulatory experience with oncology programs. Late‑stage Regulatory experience in oncology drug development is highly desired.
- Experience with cell and/or gene programs a plus, but not required .
- Must have a good understanding and experience in clinical development strategies and health authority expectations for oncology products.
- Experienced in creating and negotiating the clinical-regulatory aspects of oncology drug development programs with FDA and ex-US Health Authorities.
- Experienced in the creation, submission, and negotiation of marketing applications (NSA/BLA/MAA) preferred.
- Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents, e.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries.
- Able 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.
- High 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 inherent to an innovative therapeutic modality with an evolving regulatory environment.
This is a remote position. The budgeted salary range for this position is US$170,000 to $210,000 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.