Regulatory Affairs Manager

• This position is accountable for developing, implementing and refining processes and procedures for global regulatory affairs in line with the business objectives, and in coordination with key internal stake holders.
• Works under consultative direction toward predetermined long-range goals while also setting mid-range objectives for assigned projects.
• Determines and pursues courses of action necessary to meet the organization's objectives and schedules.
• Leads close collaboration with internal stakeholders and supports multiple projects.
• Develops and maintain GRA procedures, work instructions, and/or job aids in coordination with the process owners.
• Develops and maintains GRA Training curricula in coordination with the Regulatory Leadership Team.
• Gains alignment across GRA, Region/country, and other internal stakeholders on processes and improvement initiatives.
• Represents GRA/Regulatory Operations on cross-functional teams driving processes and improvements across Alcon.
• Identifies and executes process improvement initiatives to improve the speed and cost effectiveness of the RA organization, while also maintaining quality levels required for medical device development and support.
• Supports development, implementation, and maintenance of RA metrics to help drive performance.
• Supports Regulatory System implementation and maintenance as needed.
• Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes.
• Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
Posting Title
Regulatory Affairs Manager

Minimum requirements
• Fluent in verbal and written English communication skills.
• Bachelor's degree in a related field with 5+ years of directly related working experience OR equivalent

Job Type
Full Time

Country
USA

Work Location
Fort Worth, TX

Functional Area
Research & Development

Division
ALCON

Business Unit
GLOBAL REGULATORY AFFAIRS AL

Employment Type
Regular

Company/Legal Entity
Alcon Research, Ltd.

EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.


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