Senior Director, Regulatory Affairs Strategy & BD&L 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

Medical Devices, Eye Health, PharmaceuticalsIndustries

Requirements

Bachelor’s Degree
The ability to fluently read, write, understand and communicate in English
12 Years of Relevant Experience
8 (implied years in leadership or relevant specialization, based on context)

Responsibilities

Lead multiple departments or a large division within the Regulatory Affairs team, providing strategic leadership and ensuring compliance with regulatory requirements
Lead preparation of global regulatory plans and product strategies for assigned products
Manage and provide regulatory support on business development and licensing (BD&L) activities that align with corporate strategy
Manage and participate in conducting regulatory due diligence activities
Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports
Provide strategic product direction to teams, interact and negotiate evidence requirements with regulatory agencies, and ensure rapid and timely approval of products and their continued approval
Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations
Oversee the execution and coordination of various regulatory affairs activities, including product submissions, renewals, and updates by coordinating between plants, agents, and continuously communicating with all parties involved to ensure timely submission and approvals
Provide regulatory strategies and risk assessments/mitigation for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
Support products in either the medical device and/or pharmaceutical family of products, ensuring adherence to all relevant regulations
Lead strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills to impact multiple departments, ensure synergy across projects, drive competitive advantage through strategic decision-making, and achieve overall business outcomes
Focus on talent development to enhance capabilities
Ensure all associates adhere to Good Practice (GxP) regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
Contribute to the overall compliance of the organization and commit to continuous improvement in operations

Skills

Key technologies and capabilities for this role

Regulatory AffairsProduct RegistrationMedical Device LicensesRegulatory StrategyBusiness DevelopmentLicensingDue DiligenceQuality OversightGlobal Regulatory PlansRegulatory SubmissionsRegulatory Negotiations

Questions & Answers

Common questions about this position

What is the employment type for this Senior Director role?

This is a full-time position.

Is this role remote or does it require working at specific locations?

This information is not specified in the job description.

What key skills are required for the Senior Director, Regulatory Affairs Strategy role?

The role requires strategic leadership, cross-functional collaboration, advanced problem-solving, strong communication skills, and focus on talent development.

What is the company culture like at Alcon?

Alcon fosters an inclusive culture, recognizes contributions, offers career growth opportunities, and emphasizes innovation, progress, and making a difference in global eye health.

What makes a strong candidate for this Senior Director position?

Strong candidates will have experience leading multiple departments in Regulatory Affairs, developing global regulatory strategies, managing business development and licensing, and providing strategic direction with negotiation skills for regulatory approvals.

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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