Sr. Manager, Regulatory Affairs Strategy - Global - Pharma

Job Title: Sr. Manager, Regulatory Affairs Strategy - Global - Pharma

At 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 are currently hiring a Sr. Manager, Regulatory Affairs Strategy - Global - Pharma for Alcon, based out of New Jersey. We are looking for dynamic, inspiring, inclusive team members who collaborate with others, knowing that diverse talent, skills, and perspectives lead to better outcomes. Alcon manufacturing is a fast paced, high-energy environment so naturally we are looking for someone who is a relationship builder, an excellent analytical thinker, intuitive to business needs, and someone who can effectively communicate in challenging situations creating win-win scenarios. Above all we are looking for someone with a passion for customer service and helping Alcon in our mission to help everyone see brilliantly!

A Day in the Life:

As a Sr. Manager, Regulatory Affairs Strategy - Global - Pharma, you are responsible for unleashing the full potential of our people and culture while simultaneously achieving timely and cost-effective manufacturing of high-quality medical devices.

Global Regulatory Affairs work includes:

• Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports
• Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies
• Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions
• Serving as a regulatory liaison on the project team throughout the product lifecycle
• Participating 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 requirements •Ensuring rapid and timely approval of new drugs, biologics/biotechnology products and continued approved status of marketed drugs or medical devices •Serving as regulatory representative to marketing or research project teams and government regulatory agencies
• Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
• Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for new drugs and biologic/biotechnology products and marketed products notices.

Key Requirements/Minimum Qualifications:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand and communicate in English 
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership

Work hours: M-F 8am – 5pm

Travel Requirements: Up to 10%

Relocation assistance: none

Sponsorship available: None

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!
• Collaborate with teammates to share standard processes and findings as work evolves!
• See your career like never before with focused growth and development opportunities!
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

Alcon Careers

See your impact at alcon.com/careers

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

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