Job Title:Principal Regulatory Affairs SpecialistLocation:Lake Forest, CAAt Alcon, we are driven by the meaningful work we do to help people see brilliantly.
We innovate boldly, champion progress, and act with speed as the global leader in eye care.
Here, you’ll be recognized for your commitment and contributions and see your career like never before.
Together, we go above and beyond to make an impact in the lives of our patients and customers.We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
As a Principal Regulatory Affairs Specialist supporting our Regulatory Affairs team, you will be trusted to work on multiple lifecycle management projects and provide high quality regulatory support at our Lake Forest, CA location.
In this role, a typical day will include:Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reportsProviding strategic product direction to teams on interaction and negotiating evidence with regulatory agenciesInteracting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questionsServing as a regulatory liaison on the project team throughout the product lifecycleParticipating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC)Ensuring pre-clinical and clinical trial designs meet regulatory requirementsEnsuring rapid and timely approval of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devicesServing as regulatory representative to marketing or research project teams and government regulatory agenciesProviding advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretationsCoordinating, reviewing, and potentially preparing reports for submission in some organizations, may coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices.Key Requirements/Minimum Qualifications:Bachelor’s Degree or Equivalent years of directly related experience (or high school 13 yrs.; Assoc.9 yrs.; M.S.2 yrs.; PhD0 yrs.) The ability to fluently read, write, understand, and communicate in English 5 Years of Relevant Experience Work hours: Monday-Friday 8am-5pmTravel Requirements: 5-10%Relocation assistance: Not Available Sponsorship available: Not Available Alcon is an Equal Opportunity Employer and participates in E-Verify.
Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitmentalcon.com and let us know the nature of your request and your contact information.SummaryLocation: Lake Forest, California; Houston, Texas; Fort Worth, TexasType: Full time