Title: Senior Director Regulatory Affairs
Location: United States-New Jersey-Madison Site
The major objective for this position is set the strategic direction for Regulatory activities affecting the geo-expansion. This includes but is not limited to overseeing the development of all regulatory strategies, preparation of regulatory applications, labeling, advertising and promotional review, and life cycle management for the pharmaceutical division. The primary goal of this project is to meet the deadlines and yearly goals for regulatory submissions as established for the pharmaceutical division. It is expected that the targeted yearly submission numbers are met and/or exceeded.
A critical subtask is to oversee health authority liaison activities for all global geo-expansion submissions. Work with the local regulatory representatives to ensure proper activities with the appropriate regulatory agencies.
The primary team role for the Dir, Regulatory Affairs Geo Expansion is to act as the face for the geo-expansion team for internal and external stakeholders. You will set the regulatory direction by proactively developing new and innovative approaches for pursuing business objectives within regulatory frameworks. The Dir, Regulatory Affairs Geo Expansion will work closely with a diverse, cross-functional team consisting of clinical operations, biostatistics, pharmacovigilance and safety. As part of this team effort, the person will actively be involved in multiple projects and provide constant leadership and direction throughout the whole process.
This is your chance to expand your growth opportunities by providing leadership to a company initiative that will have a very strong impact on the pharmaceutical business unit. This role while very hands on will be instrumental in the development and evolution of this Regulatory group. Part of your development in this role will involve providing continuous strategic insight for the projects for both in licensing and existing products.
Specific Job Duties:
· Sets the regulatory direction by proactively developing new and innovative approavhes for pursuing business objectives within regulatory framework.
· Lead regulatory geo-expansion staff on a global level and ensure close collaboration with the regional regulatory representatives throughout the world.
· Set direction and strategy for global health authority meetings regarding Bausch Lomb Pharmaceutical products
· Candidates must be recognized as a regulatory expert internally and externally with in-depth knowledge of the global regulatory environment affecting the industry with a proven track record of taking products through to completion.
· They must also have solid business acumen with the ability to work effectively across diverse functions and levels within the company and understand the key interdependencies required to develop and market pharmaceutical products on a global level.
· Must have 15 years of global regulatory affairs experience. Experience with Ophthalmics is a plus.
· Advanced degree preferred (Ph.D, MBA, PharmD, JD, MD)
Managerial Responsibility:
There are currently 11 contractors globally that this person will be managing directly.Job: Regulatory Affairs
