MDWerks Inc.

MDWerks is a forward-thinking company that is leading the charge in the world of sustainable technology.

Senior Director, CMC Regulatory Affairs

ComplianceComplianceFull TimeRemoteSeniorTeam 1-10H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

41 days ago

Salary

$240K - $270K / year

Seniority

Senior

Postgraduate Degree10 yrs expExperience acceptedEnglish

Job Description

• Leading the development, execution, and maintenance of global CMC regulatory strategy to support clinical development, registration, commercialization and lifecycle management of Mineralys products. • Providing strategic and operational leadership for all CMC-related regulatory activities. • Supporting cross-functional decision-making by providing regulatory guidance. • Ensuring compliance of CMC documentation and high-quality submissions that meet global regulatory requirements and support business objectives. • Partnering closely with CMC, Quality, and external partners to ensure alignment of CMC documentation, regulatory strategy, product lifecycle planning and management.

Job Requirements

Advanced degree (MS, PhD, PharmD) in Chemistry, Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or related scientific discipline; Bachelor’s degree with extensive experience acceptable.
Minimum 10 + years of pharmaceutical/biotech experience with 8 + years CMC regulatory experience.
Proven record of leading global CMC strategy, submission, and agency interactions (FDA, EMA, PMDA etc.) in both pre- and post-marketing settings.
Strong knowledge of global CMC regulatory requirements, ICH guidelines, and submission standards.
Demonstrated ability to interpret and apply regulatory guidance to complex CMC issues and lifecycle activities.
Experience with regulatory submission management tools and electronic submission systems.
Solid understanding of quality management systems including change controls, documentation management systems.
Ability to work effectively in a fast-paced and results-focused environment and on matrix teams.

Benefits

These positions are eligible for standard Company benefits including medical, dental, vision, time off and 401K
Participating in Mineralys incentive plans are contingent on achievement of personal and company performance.