Director, Regulatory Affairs Operations & Publishing (Pharma) 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

Pharmaceuticals, HealthcareIndustries

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)
Ability to fluently read, write, understand and communicate in English
10 Years of Relevant Experience
6 Years of Demonstrated Leadership
Willingness to travel minimally
Ability to work onsite in Fort Worth, TX (or other Alcon locations subject to business needs)

Responsibilities

Lead and mentor teams in dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling
Maintain and drive continuous improvement initiatives for the Veeva RIM Suite and facilitate its rollout to cross-functional teams
Foster strong relationships with regulatory staff and cross-functional teams to prioritize compliant submissions
Develop and implement strategies to ensure departmental success and alignment with company goals
Develop and maintain standard operating procedures (SOPs) for regulatory processes and manage regulatory filing systems
Oversee submission planning, formatting, publishing, and archiving
Make key decisions impacting department performance and success
Ensure timely and accurate submission of regulatory documents
Adhere to Good Practice (GxP) regulations by following SOPs, maintaining accurate and complete documentation, ensuring rigorous quality control, completing all required training, and contributing to overall organizational compliance

Skills

Key technologies and capabilities for this role

Regulatory AffairsDossier PreparationVeeva RIMSubmission ManagementPublishingClinical Trial DisclosureSOP DevelopmentGxPRegulatory SubmissionsLicensingLabeling

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A Bachelor’s Degree or equivalent years of directly related experience is required, along with 10 years of relevant experience and 6 years of demonstrated leadership.

Is this position remote or does it require office work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What is the company culture like at Alcon?

Alcon fosters an inclusive culture, recognizing contributions and offering opportunities to grow your career, while innovating fearlessly, championing progress, and acting swiftly to impact global eye health.

What makes a strong candidate for this Director role?

Strong candidates will have a Bachelor’s Degree or equivalent, 10 years of relevant regulatory affairs experience, 6 years of leadership, and fluency in English to lead teams in submissions and Veeva RIM.

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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