Dennis Partners · 1 month ago
Vice President of Regulatory Affairs
Greater Boston
Full-time
Onsite
Director/Executive
$325K/yr - $350K/yr
15+ years expDennis Partners is a pharmaceutical company dedicated to developing innovative therapeutics for serious retinal diseases. They are looking for a Vice President of Regulatory Affairs to lead regulatory strategy, manage submissions, and ensure compliance while collaborating with various teams and regulatory agencies.
BiotechnologyConsultingHuman ResourcesRecruitingStaffing Agency
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
Qualification
Required
Bachelor degree in a scientific discipline
15+ years of Drug Development and Regulatory Affairs experience
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
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
Expertise in communication and organizational skills as well as hands-on experience with international clinical development
Demonstrated knowledge of worldwide drug guidelines and regulations and in particular US FDA
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
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
Preferred
Advanced degree (MS, PharmD or PhD)
Regulatory experience with drug-device combination products
2 years of experience as of participating in MLRC (or PRC) project reviewer will be an asset
Benefits
Annual target bonus
Equity
Comprehensive benefits
Company
Dennis Partners
Dennis Partners specializes in regulatory recruiting for the biotech and pharmaceutical industries.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Jilma Sweeney
President
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