- Leads multidisciplinary teams on the content, format, style and architecture of an Investigational New Drug (IND) application, Clinical Trials Application (CTA), Investigational Medicinal Product Dossier (IMPD) and New Drug Application (NDA). Writes and/or reviews submission sections and evaluates relative to strategy and for conformance with the regulatory requirements.
- Contributes to multidisciplinary teams on the regulatory strategy for drug development including CMC, preclinical, clinical and/or commercial requirements at different stages of development. Applies and advanced knowledge of U.S. and international requirements /guidelines applicable to same.
- Oversees global communications to Regulatory Authorities by our corporation on all aspects of a product offering: annual updates, clinical trials (INDs and CTAs), responses to requests for information, in accordance with company policies and practices.
- Liaisons with competent regulatory authorities on routine matters and serve as the Company's lead for regulatory meetings with Agencies.
- Reviews critical analyses of data (clinical, preclinical and manufacturing) and independently develops interpretations and conclusions; performs meaningful reviews of clinical/preclinical/manufacturing protocols and studies reports.
- Maintains responsibility for the regulatory strategy related to life cycle maintenance of marketed and pre-market product offerings
- Closely collaborates with R&D, Clinical and Statistical team members, and other key partners both internal and external to the company, aimed at ensuring regulatory documentation meets project target dates.
- 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.
- Reviews Technical Operations, and Development documentation for regulatory compliance; including validation protocols, close out reports, analytical methods, batch records and any other CMC related documentation.
- Serves as the primary contact for all submission documentation and questions, ensuring they are completed in accordance with regulations, and collaborate on final versions.
- May manage the performance and development of staff. Leads training on applicable requirements for staff as required.
- Communicates our organization's regulatory information and status to distributors and business partners.
- Leverages an in-depth understanding of the overall business environment, the industry and the marketplace to contribute to business objectives.
- Oversees continuous updating of local product offering labeling to accurately reflect the Core Product Labeling Profile (CPLP,) working with external in-country contract regulatory resources.
- Maintains current knowledge of and ensures 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 of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- Bachelor's degree (Advanced Degree Preferred) with 8-10 years' experience in a pharmaceutical regulatory environment with primary contacts at FDA and other health authorities, or equivalent.
- Occasional overnight travel based on business need.
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone's health is in our hands
- Own the solution and make it happen
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Director, Regulatory Affairs - Bedford, United States - Lantheus
Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of Role
Responsible for integrating and applying advanced knowledge of global regulations governing pharmaceutical drug development and commercialization to all aspects of assigned preclinical and/or clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all regulatory requirements and commitments. Evaluates proposed regulations and advises on impact of such regulations on the company; may provide advice and counsel with respect to product labeling and literature relative to compliance with applicable regulations; collaborates with counsel and external consultants globally in representing the company's interests.
At this level, the incumbent independently manages a major segment of the Company's regulatory effort and serves as the prime regulatory 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.
Essential Functions
The ideal candidate will embody Lantheus core values:
