Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Director Regulatory Affairs - OTC drives the development and implementation of the Company’s global regulatory strategy for development and marketed OTC products within the Vision Care Franchise to deliver timely approvals of Alcon products with optimal product labelling to facilitate market success.
The Director is responsible for the global regulatory strategies to optimize the commercial success of the OTC marketed products.
The Director is responsible for ensuring close collaboration both within GRA and between GRA and other functions in support of the OTC portfolio.
The Director will maintain close collaboration with key GRA stakeholders to ensure stakeholder input is integrated into the overall global strategies for OTC projects and brands.
Develop and direct a team of RA professionals for: Expeditious and effective preparation and execution of all reporting requirements (e.g. Annual Reports, PSURs, Drug Listings) for Alcon’s US licenses and through country regulatory organization for X-US licenses.
Expeditious and effective preparation and execution of all labeling updates for Alcon’s US licenses and through country regulatory organization for X-US licenses.
Expeditious and effective preparation and execution of all dossier updates (CTD and eCTD) and maintenance activities for Alcon’s US licenses and through the country regulatory organizations for X-US licenses.
Develop and Maintain excellent working relationships with US health authorities; identify regulatory risks for marketed products and develop strategies to minimize those risks.
Ensure appropriate Regulatory compliance in all aspects for marketed products.
Work as a key team player, exhibiting leadership in the formulation and execution of regulatory strategy.
Ensure sound regulatory practices are fully integrated in all technical submissions and evaluate all documents submitted to regulatory agencies to ensure they are complete, well organized, scientifically accurate, of high quality, in regulatory compliance, and presented in a manner that facilitates review.
Bachelor’s degree in relevant discipline.
Proficient use of the English language (both oral and written)
Additional Salary Information: This position has a lucrative benefits package including a strong base salary, bonus potential, Long Term Incentive plan participation, full medical dental vision and 401K benefits with a strong match and employer contribution program.
Internal Number: 234090BR
About Alcon, A Novartis Division
As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs. We have one mission: to discover new ways to enhance sight and improve people’s lives. Together with Novartis, we offer the widest spectrum of products in eye care. This enables us to serve our customers through the full life cycle of patient needs across eye diseases, vision conditions and refractive errors. Our vision is to be the most trusted leader in eye care. By serving and working with people worldwide, we are building our reputation, while addressing the growing eye care demands of the future. At Alcon, we recognize that our success depends on the creativity, dedication and performance of our associates. That’s why we foster a performance-oriented culture that encourages achievement through collaboration and innovation. This culture is reflected in our product pipeline, one of the most exciting in the industry today. We depend on our diverse and talented associates to bring a full spectrum of innovative medicines and devices to patients that address their eye care needs, creating one of the most rewarding work environments in our industry.