Our client is developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders. They are seeking a Regulatory Affairs Strategy Director or Associate Director who can develop and execute global regulatory strategy plans for their clinical-stage ophthalmology programs. Reporting into the Chief Regulatory Officer, you will work closely with cross-functional teams and Health Authorities to achieve successful regulatory filings. This company offers a science-based, entrepreneurial culture, excellent employee benefits, and flexible work arrangements. With one approved product and their lead program going into global Phase three studies, now is an exciting time to join this growing organization!
Responsibilities:
- Assist the Chief Regulatory Officer in designing and implementing regulatory strategy plans for assigned ophthalmic drug programs.
- Work closely and collaboratively with Regulatory Operations and Regulatory CMC to ensure high-quality and timely submissions to Regulatory Agencies including initial INDs, CTAs, NDAs, amendments, supplements, and Pediatric Study Plans.
- Interface directly with US FDA and acts as primary liaison to FDA.
- Author health authority responses alongside subject matter experts, working with cross-functional teams through submission deliverables.
- Review administrative forms, cover letters, general correspondences. Manage the routine maintenance of open regulatory applications.
- Coordinate with Regulatory Operations and Regulatory CMC the submission planning of new applications, supplements or amendments and other regulatory filings both inside and outside the USA.
- Work closely with Chief Regulatory Officer to prepare and facilitate informal and formal regulatory meetings aligned with established regulatory and development strategies.
- Establish and maintain excellent working relationships and well-organized communications with US FDA representatives or other Health Agencies.
- In coordination with Chief Regulatory Officer, prepare regulatory risks assessment, and strategic plans, draft and maintain annotated labeling, and review for adequacy labeling components.
- Assist the Chief Regulatory Officer in the Advertising and Promotional Review and submission (FDA 2253) process.
- Ensure that contents of submission are document are complete, accurate and compliant with health authority publishing specifications, the company style guide and template specifications.
- Contribute to improvements in department best practices and SOPs.
- Performs other duties as required, interfacing with other departments, CROs, and external vendors.
- Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
- Archive and maintain regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs.
- This is a ‘hands on’ position where an individual must be versatile and capable of managing the operational workload that goes along with strategy execution.
Qualifications:
- Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- Six or more years of Clinical Regulatory Affairs experience for pharmaceutical drugs or biologics.
- Ophthalmology and/or Retinal disease experience highly desired.
- Experience and knowledge in preparation of INDs, CTAs, NDAs and supportive amendments or supplements.
- Must have experience working directly with the FDA and global regulatory authorities.
- Experience with drug-device combination products desired but not required.
- Working knowledge of eCTD elements and structure, ICH standards and submission requirements.
- Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
- Strong communication skills and strong regulatory writing skills.
- Ability to balance multiple tasks to meet priorities and timelines.
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
- Able to be flexible and comfortable with ambiguity.
This is a hybrid/onsite position in the Greater Boston Area. This individual must be onsite 2-3 days a week.
The budgeted salary range for this position is US$180,000 to $240,000 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 remuneration.