1871 Regulatory Affairs CMC Manager
With 7 commercial products and counting, a rich pipeline of mid- to late-stage development candidates and a personal connection to our patients, the Company is the recognized industry leader in rare disease development.
This is an exciting time to join the Company and to contribute to the exciting portfolio of products. Come work in an entrepreneurial environment where you’ll have the resources and infrastructure combined with visibility and opportunity to tangibly impact patient’s lives and the future of our company.
As a Manager in Regulatory Affairs, CMC, you will be responsible/accountable for:
Proactively managing and supporting Chemistry, Manufacturing & Controls (CMC) aspects of the Company’s commercial and/or clinical programs.
Timely preparation and submissions of global regulatory filings including, clinical trial and marketing applications, post-approval variations and license maintenance activities.
Researching and interpreting global CMC regulations and provide regulatory guidance to Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization.
Process GMP documentation to support global submissions.
Developing excellent relationships with colleagues and cross-functional stakeholders in WWRD and Technical Operations.
At least 5 years of experience in Regulatory Affairs or related discipline in the pharmaceutical or biotechnology industry, preferably with exposure to both development and commercial phases of product lifecycle.
Combination products experience desirable.
Experience in management and filing of marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the US, EU and ROW markets.
Developing partnership with Reg CMC Lead (Product, EU, Site) for strategic alignment, collaboration, and information sharing to meet project goals and timelines.
Developing relationships with internal functional groups, contract manufacturing organizations, and corporate partners in order to communicate relevant CMC regulatory issues, topics, and questions relating to assigned work.
Represent the Regulatory Affairs CMC function on assigned cross-functional project teams, relevant site, or global meetings.
Communicate with stakeholders, peers, and supervisors.
Support monitoring Reg CMC preparation, review and submission timelines.
Education: BA/BS degree in life sciences in chemistry, molecular biology, or similar is required. Advanced degree preferred.