Director, Regulatory Affairs Operations at Alcon

Fort Worth, Texas, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
The ability to fluently read, write, understand and communicate in English
10 Years of Relevant Experience
6 Years of Demonstrated Leadership
Travel: 10-20% Domestic
Work Location: Onsite – Fort Worth, TX (This role may be based at other Alcon locations, subject to business needs)
Relocation: Yes

Responsibilities

Lead and mentor teams in dossier preparation, Clinical Trial Disclosure, submission management, and submission publishing
Maintain and drive continuous improvement initiatives for the Veeva RIM Suite and facilitate its rollout to cross-functional teams
Create job aids detailing document approval processes, workflows, and submission tracking
Provide user requirements and recommendations for Veeva auto releases and configurations and update associated Standard Operating Procedures (SOPs) in line with process improvements and auto releases
Foster strong relationships with regulatory staff and cross-functional teams to prioritize compliant submissions
Maintain oversight of the product support request tool and ensure all requests for documentation in support of marketing applications are fulfilled in a timely manner
Develop and implement strategies to ensure departmental success and alignment with company goals
Make key decisions impacting department performance and success
Ensure timely and accurate submission of regulatory documents
Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and ensuring rigorous quality control
Complete all required training and contribute to the overall compliance of the organization by committing to continuous improvement and adherence to regulatory requirements
Direct product/process registration submissions and provide strategic product direction to teams
Build effective relationships with regulatory agencies to expedite approvals and address inquiries
Support the medical device portfolio of products across the Surgical and Vision Care Franchises

Skills

Regulatory Affairs

Veeva RIM

Dossier Preparation

Submission Management

Clinical Trial Disclosure

SOPs

Regulatory Submissions

Process Improvement

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

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