Dennis Partners

This commercial-stage biopharmaceutical company is focused on developing, manufacturing, and commercializing innovative therapies for diseases and conditions of the eye. They are seeking a Regulatory Affairs Executive Director who can develop and implement global regulatory strategies for their portfolio of clinical programs. Reporting into the Vice President of Regulatory Affairs, you will manage assets through all phases of development and work on an upcoming NDA. This company offers an innovative pipeline, a collaborative company culture, and flexible work arrangements. With their lead candidate currently in Phase 3 trials, now is an exciting time to join this organization! Responsibilities: Ensure the development and execution of global regulatory strategies for a portfolio of ophthalmic drug/device combination programs across all phases of development. Responsible for assisting in the preparation and compilation of domestic and international product submissions. This may include, but is not limited to: INDs, IMPDs, global CTAs, NDAs, MAAs, NDS and any other regulatory application as directed. Work closely with cross functional teams on an upcoming NDA for their Phase 3 program. Work closely with Health Authorities. This includes FDA meetings, teleconferences, and responding to Health Authority inquiries. Oversee all lifecycle maintenance filings (e.g. CMC supplements/notifications, 2253 submissions, annual reports, efficacy supplements and safety reporting). Ensure that agency establishment registrations and device/drug listings are completed on time. Assist with the preparation and compilation of regulatory information requested during regulatory inspections. Support domestic and international field corrective actions and adverse event reporting, when necessary. Assist in the development and submission of any necessary global CTAs, maintain global CTAs throughout development lifecycle for pharmaceutical products. Review product and process documentation for assigned projects to ensure compliance with regulatory dossiers. Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes. Coordinate development and submission of annual Developmental Safety Update Reports. Provide regulatory research information as requested. Manage one or more direct reports. Perform other regulatory affairs duties when requested. Qualifications: Advanced degree (MS, PharmD or PhD) in a scientific discipline highly preferred. 10+ years in Regulatory Affairs for pharmaceutical drugs. Regulatory experience with ophthalmic programs is required. Must have drug development experience in the US, EU and UK. Experience in other parts of the world is a plus. Experience directly interfacing with health authorities in major markets (FDA, EMA, MHRA) is a must. Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy. Must have experience filing major marketing applications (NDAs, MAAs, BLAs, etc.) Demonstrated experience in preparing and gaining acceptance for all types of US based submissions, global investigational and commercial submission experience preferred. Proven track record of increasing responsibilities with skills in leadership and management. Strong technical writing skills for authoring regulatory submission documents. Some experience managing direct reports in Regulatory Affairs. Excellent communication skills, with the ability to articulate complex issues clearly and persuasively. Must be flexible and comfortable with ambiguity in a fast-paced, small company environment. This is a hybrid position in the Boston area. Candidates in the Northeast are strongly preferred and regular travel to the Massachusetts office will be required. The budgeted salary range for this position is US$275,000 to $300,000 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 clinical-stage biotech company utilizes a proprietary platform to develop precision therapeutics for cancers and other diseases. They are seeking a Vice President of Regulatory Affairs to develop and lead global regulatory strategies for their portfolio of programs and serve as the primary contact with health authorities. You will provide crucial input to the organization to advance their pipeline towards approval. This is the first FTE regulatory hire for this company and this role initially will be an individual contributor position with consultancy support. This company offers innovative science, a collaborative company culture, and flexible work arrangements. With their lead candidate in Phase 1 trials and a new IND planned for early this year, now is an exciting time to join this growing organization! Responsibilities: Build and lead the Regulatory Affairs function, ensuring adherence to regulatory standards and requirements for the company. Develop and lead global regulatory strategies for a portfolio of oncology programs. Balance strategy with execution in a hands-on leadership role. Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings. Provide key updates and guidance on Regulatory activities to Executive Team and Board of Directors as needed. Play a core role in project teams, developing global regulatory strategies for drug development programs, including clinical and pre-clinical stage programs. Coordinate and manage regulatory submissions (e.g. INDs, clinical trial applications, marketing applications) in collaboration with multi-disciplinary development teams as well as senior management. Contribute to the creation of the overall product development strategy and manage the development, monitoring, and delivery of Regulatory project plans throughout the life cycle. Provide input on development plans, Target Product Profile (TPP) development, risk assessments, resource planning, and other documents as required. Lead regulatory meeting preparation efforts supported by the program team. Ensure on-time, high-quality and regulatory-compliant submissions. Liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions. Build key infrastructure for Regulatory to support the development, approval, and launch of products. Hire and manage direct reports and consultants. Coach, develop, and mentor other team members. Train others on regulatory requirements as needed. Develop and maintain partnerships and networks to support delivery of regulatory goals. Forecast budgets and develop department best practices and SOPs. Qualifications: Bachelors in a scientific discipline required. Advanced degree (eg. MS, MD PharmD, or PhD) preferred. A minimum of 10 years of Regulatory Affairs experience in the biopharmaceutical industry. Must have strong Regulatory experience with oncology programs. Experience supporting both early and mid-phase development, including development and filing of associated regulatory submissions. Experience with Companion Diagnostics a plus but not required A track record of successful interaction with FDA and other regulatory agencies. EMA, Ex-US or global regulatory experience required. Some experience with CMC Regulatory a plus. Experience with alternative regulatory pathways (e.g. breakthrough designation, priority review, fast track) strongly preferred. Must be an experienced, hands-on-problem-solver who can develop a broad vision for a unique regulatory strategy while supporting ongoing activities on a day to day basis. Ability to review, understand and explain the regulations and guidance documents to guide project teams. In-depth understanding of the drug development, product commercialization and life cycle management processes. Leadership, Interpersonal and Soft Skills: Strong track record working with program teams to advance development assets is essential. Previous Regulatory team leadership desired. Outstanding written, oral, organizational, and interpersonal skills. Ability to collaborate effectively with internal and external key stakeholders. Must be comfortable wearing many hats in a small biotech environment and have a "can do" attitude. This is a hybrid position in the Greater Boston Area. Local candidates in the Boston Area will be onsite 3 days a week. Candidates outside of the Boston area will be expected to be in the office at least one week per month. The budgeted salary range for this position is $300,000 to $350,000 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.