Our client is developing new biologic-based treatments for a broad range of unmet medical needs. They are seeking a Regulatory Affairs Director or Senior Director who can provide regulatory leadership and execution in all areas of development for their portfolio of programs. Reporting into the Chief Medical Officer, you will work closely with cross-functional teams and Health Authorities to advance their pipeline and ensure regulatory success. This company offers innovative science, a collaborative, patient-focused company culture, and a hybrid work model. With their lead program going into Phase 2 studies, now is an exciting time to join this growing organization!
Responsibilities:
- Provide regulatory strategy and execution for a portfolio of biologic-based programs, including cardiovascular and rare disease indications.
- Act as primary contact with the FDA and other regulatory agencies.
- Lead the compilation, review, and submission of all lNDs, CTAs, marketing applications, other regulatory filings.
- Apply extensive knowledge of FDA and ICH guidelines to support corporate goals.
- Ensure that contents of submission are document are complete, accurate and compliant with health authority publishing specifications, the company style guide and template specifications.
- Prepare for meetings with FDA and other health authorities.
- Contribute to improvements in department best practices and SOPs.
- Performs other duties as required, interfacing with other departments, CROs, and external vendors.
- Forecast budget based on expert understanding and industry experience.
- Provide counsel, training, and interpretation of global regulatory guidelines.
- Provide critical evaluation of potential product opportunities, partnering and licensing activities for business development.
Qualifications:
- Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- 10 or more years of experience in Regulatory Affairs for pharmaceutical drugs and/or other therapeutics.
- Regulatory experience with biologic therapeutics desired.
- Therapeutic experience with Cardiovascular indications and/or Rare Disease a plus.
- Must have experience working directly with FDA. Experience with other health authorities (EMA, Health Canada, etc) a plus.
- Experience in designing, writing, and submission of regulatory filings (INDs, CTAs, NDAs, etc) and other correspondence.
- Mid-stage experience into Phase 3 preferred.
- Strong understanding of the global pharmaceutical drug development and regulatory environment.
- Some experience with CMC Regulatory a plus but not required.
- Strong leadership competencies and strategic business perspectives.
- In-depth understanding of the drug development, product commercialization and life cycle management processes.
- Excellent oral and written communications skills.
- Must be entrepreneurial, innovative, energetic, hands-on, and team oriented.
- Ability to build cross-functional relationships and work collaboratively. Ability to think strategically and execute.
- Must be flexible and comfortable with ambiguity in a small company environment.
This is a hybrid-onsite position in the Boston area. Candidates in the Boston area are highly preferred, but other candidates in the Northeast may be considered.
The budgeted salary range for this position is US$200,000 to $275,000 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.