Imbria Pharmaceuticals’ mission is to translate our understanding of cellular metabolism into innovative medicines that improve the lives of patients with limited or inadequate treatment options. The company was founded by doctors and launched by an all doctor executive team motivated by the promise of bringing new therapies to people in need.
We are propelled by a deep scientific interest in cellular metabolism and the mitochondria, and are guided by both values and a code of business conduct built upon our commitment to always put the patients, families and communities we serve at the forefront of all that we do. More information can be found at www.imbria.com.
The Senior Director, Regulatory Affairs, reporting to the Chief Medical Officer, will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for products through all development phases. The Senior Director Regulatory Affairs will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for US FDA, EMA, and other key market Health Authorities as applicable and ensure these activities are consistent with the overall global strategy and activities. An integral part of this role is to foster strong relationships and advocacy with FDA as well as other international regulatory authorities, as required. This leadership role will entail oversight of CROs for the preparation of the regulatory submissions and interaction with key members of the Project Teams, agencies/health authorities to obtain and maintain product approvals.
- Develop, lead and implement global regulatory strategy.
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities, including meeting requests, briefing packages, and fast track applications.
- Act as primary strategic contact with the US FDA, EMA, and other key market Health Authorities as applicable to enable execution of company regulatory goals.
- Partner with the CRO in developing and leading all regulatory strategies and activities
- Provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
- Provide direct Regulatory oversight to all Non-clinical, Clinical and CMC activities.
- Lead the preparation of submissions, which may include INDs, Briefing Documents, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
- In collaboration with appropriate team members (e.g., clinical development, clinical operations, biostatistics) assist in the design of clinical study protocols, development of statistical and interim analysis plans, and interpretation of clinical study data.
- Support preparation of Pediatric Study Plans and other pediatric applications
- Support preparation of Orphan drug designation requests for submission to FDA & EMA
- Provide input to the Regulatory Affairs portion of proposals, budgets and contracts
- Identify and assess regulatory risks for projects or programs.
- Participate in audits as required; oversee follow-up activities and ensure timely implementation and completion of corrective action plans in close cooperation with QA.
- Support product launch and commercialization activities.
- Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Company personnel and assist as a liaison between the Company and regulatory authorities.
- Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future products.
- Communicate project regulatory strategies and plans to management, cross functional teams and any partners/collaborators to establish alignment.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice.
- Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
- Participates in Business Development efforts, as assigned.
Minimum Education, Experience, Knowledge and Skills Required:
- Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 15+ years pharmaceutical industry experience, including 10 years in Regulatory Affairs. Global experience desired.
- Experience in multiple phases of development in various therapeutic areas. Experience in cardiovascular therapeutic areas a plus.
- Experience leading a Regulatory Affairs function, specifically the designing, writing, and submission of regulatory filings and correspondence within a complex specialty/branded commercial pharmaceutical organization. Preferred candidates will have experience leading the submission process for both new entities and line extensions of existing products. Experience supporting commercialization and post-marketing activities and requirements for approved products in North America.
- Strong leadership competencies and strategic business perspectives are required to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and post-marketing activities.
- Knowledge of the drug development process and global submission process.
- Demonstrated experience in preparing FDA submissions.
- Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
- High level partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
- Must be able to innovate, analyze and solve problems with attention to detail.
- S/he must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. This person will demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. S/he will be entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details.
- Domestic and occasional International travel may be necessary.
Imbria offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to email@example.com.