North Billerica, MA
In this key role you will be responsible for integrating and applying advanced knowledge of global regulations governing all aspects of pharmaceutical drug development and commercialization to all assigned preclinical and/or clinical drug development programs, policies, and procedures. You'll lead efforts in collaboration with other functional leaders to ensure the rapid and successful registration and approval of products while maintaining compliance with all regulatory requirements and commitments. Leads global regulatory efforts to modify and improve commercial products from a product life-cycle perspective and ensures that post approval changes are managed in a compliant manner.
At this level, the incumbent is one of the Company’s most senior regulatory experts and will independently manage a major segment of the Company’s regulatory effort and serves as the prime regulatory clinical development consultant and external spokesperson on key matters with regulatory agencies and the Company’s top management; works under consultative direction toward long-range goals and objectives and provides strategies to troubleshoot issues that arise during a products life-cycle.
- Leads independently multidisciplinary teams on the content, format, style and architecture of marketing applications and develops robust strategies for gaining regulatory approval.
- Develops briefing packages, fast track applications, orphan drug, rare pediatric disease applications for meetings with global regulatory agencies.
- Provides regulatory expertise and support for drug development including clinical, preclinical, and/or commercial requirements at different stages of development. Applies an advanced knowledge of U.S. and international requirements /guidelines as they apply to different stages of development and commercialization.
- Writes and/or reviews submission sections to support IND, CTA and NDA applications, evaluates the aspects relative to strategy and serves as the primary regulatory contact for documentation materials and questions, ensuring they are completed in accordance with regulations/requirements, and collaborate on final versions.
- Initiates, oversees and signs global communications to Regulatory Authorities by our corporation on all aspects of a product offering: annual updates, clinical trials, responses to requests for information, in accordance with company policies and practices.
- Liaisons with competent regulatory authorities on strategic matters and serve as the Company’s lead for regulatory meetings with Agencies for their assigned programs.
- Ensures team members, and other key partners both internal and external to the company meet regulatory submission deadlines and maintains expected timelines.
- Executes compilation of pre- and, post-approval regulatory submissions including annual reports, renewals, supplemental applications briefing packages for FDA meetings or EU scientific advice procedures and other maintenance dossiers and coordinate responses to health authority questions and comments.
- Leverages an in-depth understanding of the overall business environment, the industry and the marketplace to contribute to business objectives.
- Manages and fosters the growth of the work team to support the long term growth and corporate strategies. Oversees full range of performance management processes and training and development needs of functional team. Leads and motivates team, provides feedback, coaching, and counseling to enhance or improve performance. Sets clear, concise expectations and holds individuals accountable for performance and behavior.
- Develops and maintains strong working relationships with key stakeholders across multiple internal work teams. Drives Regulatory Affairs alignment to key strategies and action plans.
- Maintains current knowledge of, and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the Lantheus values.
- Bachelor’s degree with 15+ years’ experience in a pharmaceutical regulatory environment with primary contacts at FDA and other health authorities, or equivalent.
- Excellent interpersonal skills, oral and written communication skills.
- Can work both independently and within project teams, committees to attain individual and group goals.
- Strong organizational skills including the ability to prioritize personal and direct reports workload.
- Ability to represent the department in project teams.
- Experience in interpretation of regulations, guidelines and policies.
- Experience in preparing IND and NDA submission filings.
- Experience leading regulatory agency meetings in different phases of drug development.
- Routine overnight travel based on business need.