This pharmaceutical company is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. They are seeking a Vice President of Regulatory Affairs to provide team leadership and strategic input for their product portfolio. Reporting into the Chief Regulatory & Quality Officer, the Vice President will be responsible for overseeing overall regulatory strategy in close collaboration with Reg CMC and Regulatory Operations functions, managing compounds through development for regulatory approval, as well as life cycle management of marketed products. This individual will oversee an upcoming NDA submission, focusing on managing non-clinical, clinical, label/labeling development and maintenance, and overseeing Medical Legal Regulatory Review Committee of Advertising Promotional Review process, and work closely with Health Authorities. This company offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity. With their lead candidate currently in Phase 3 trials, now an exciting time to join this growing organization!
Responsibilities:
- Lead the Regulatory Affairs functional areas to ensure adherence to regulatory standards and requirements for the company.
- Develop global regulatory strategies for drug development programs, including clinical-stage ophthalmology drugs and drug-device combination products. 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.
- Serve as primary contact with FDA and other regulatory agencies, leading all communications and meetings.
- Provide input on development plans, Target Product Profile (TPP) development, risk assessments, resource planning, and other documents as required.
- Provides recommendations to decision makers on regulatory strategies and options on new products or claims that balance business needs with regulatory oversight.
- Interprets and translates regulatory requirements into business opportunities.
- Manage labeling and labels creation, development and maintenance including managing Labeling Review Committee (LRC) projects, working closely with RegOpS and members of the LRC. Ensure that optimal labeling /labels is negotiated with FDA during NDA review and for post-approval changes.
- Manage and ensure process is in place for review and approval of advertising and promotion to ensure regulatory compliance. Review and approve enforcement action/ responses.
- Coordinate and manage regulatory submissions (e.g. INDs, clinical trial applications, marketing applications, etc.) in collaboration with multi-disciplinary development teams.
- Represent Regulatory Affairs on project teams & liaise with regulatory publishing and other ancillary regulatory functions at CROs and consultants to coordinate regulatory submissions.
- Ensure on-time, high-quality and regulatory–compliant submissions.
- Lead regulatory meeting preparation efforts supported by the Project Team;
- Hire and manage direct reports and consultants, as appropriate.
- Provide key updates and guidance on Regulatory activities to Chief Regulatory & Quality Officer, as needed.
- Oversee Regulatory infrastructure to support the development, approval, and launch of products.
- Forecast budgets and develop department best practices and SOPs.
- Oversee regulatory matters with licensing partners.
- Serve as subject matter expert in global regulatory processes, laws, and regulations, particularly within the U.S. with FDA.
Qualifications:
- Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- 15+ years of Drug Development and Regulatory Affairs experience.
- Experience developing and implementing global regulatory strategies.
- Must have 3+ years with Ophthalmology programs and/or Retinal disease experience.
- Previous Regulatory team management and leadership experience leading direct teams and through a matrix environment.
- Track record of successful NDA, BLA and/or MAA filings.
- Must be familiar with Advertising & Promotional requirements. 2 years of experience as of participating in MLRC (or PRC) project reviewer will be an asset.
- Must have proven experience of participating in labeling/label development and maintenance, at least 3 years.
- Must have experience working directly with the FDA and global regulatory authorities.
- Regulatory experience with drug-device combination products a plus.
- Expertise in communication and organizational skills as well as hands-on experience with international clinical development. Track record of successful interactions with regulatory and health authorities on an international level.
- Demonstrated knowledge of worldwide drug guidelines and regulations and in particular US FDA.
Interpersonal, Leadership, and Soft Skills:
- Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity.
- Strong relationship management and interpersonal skills are essential.
- Proven ability to hire, build, and lead a Regulatory team.
- Must be humble with low ego.
- Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity. Strong relationship management and interpersonal skills are essential
- Natural collaborator who enjoys working on a cross-functional team.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
- Must be comfortable being an individual contributor, a team player, and a team leader.
- Proven ability to lead cross-functional teams, serving as a strategic and tactical bridge between multiple areas.
- Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
This is a hybrid onsite position in the Greater Boston Area (3 days per week). NOTE: Our client prefers candidates in the Greater Boston Area or elsewhere in the Northeast. Relocation package is available for the right candidate.
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.