Apply on Employer Site

Alcon · 1 day ago

Senior Director, Regulatory Affairs CMC

Fort Worth, TX

Full-time

Onsite

Director/Executive

12+ years exp

Alcon is a company dedicated to enhancing sight and improving eye health globally. The Sr. Director of Regulatory Affairs CMC is responsible for leading global CMC regulatory strategies, ensuring compliance with regulations, and guiding the team through regulatory challenges while overseeing CMC submissions and engaging with health authorities.

Health CareManufacturingMedical Device

No H1B

Responsibilities

Lead development and implementation of global CMC regulatory practices and strategies to support product development throughout the lifecycle of biologics, pharmaceuticals, and combination products maintaining regulatory compliance to drive competitive advantage

Design and direct the development of Regulatory Affairs CMC team and capabilities to streamline regulatory support for CMC related projects and activities

Oversee all of Alcon’s global CMC submissions, including initial market registrations, progress reports, supplements, amendments, and annual reports

Represent the company in communications and meetings with health authorities to expedite approval of pending registrations and address questions

Proactively identify risk areas, develop alternative courses of action, and assess the impact of new regulations to prepare the team to implement necessary changes

Lead the development of company policy and positions on draft regulations and guidance

Demonstrate strategic thinking, advanced regulatory knowledge, excellent communication, leadership, and problem-solving abilities

Oversee and serve as primary decision-maker for CMC regulatory assessment and acquisition/integration strategy for business development and licensing activities

Attract, retain and develop Regulatory Affairs CMC talent

Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training

Meet individual job requirements and contribute to overall organizational compliance while committing to continuous improvement and compliance with regulatory requirements

Qualification

Global CMC regulatory strategiesRegulatory complianceLeadershipBiologicsPharmaceuticalsRisk assessmentEnglish communicationProblem-solvingStrategic thinking