Senior Manager Regulatory Affairs, CMC and Regulatory Sciences

Meitheal Pharmaceuticals Inc • Chicago, IL

18d • $120,000 - $155,000 • Hybrid

About The Position

Senior manager of Regulatory Affairs, CMC & Regulatory Sciences will be responsible for providing regulatory guidance to product development, supporting and reviewing CMC sessions in submissions & deficiency responses, aiming for efficient and robust product development and high-quality regulatory submissions, primarily for biosimilars. S/he will work closely with the management team of Regulatory department to develop regulatory strategies for both projects and portfolios of biosimilars, contributing to the transformation and growth of regulatory team to meet the needs of company's business growth toward biopharmaceuticals.

Requirements

• Master or Ph.D. 's degree in life sciences; over 6 years related experience in product development and/or regulatory CMC; or equivalent combination of education and experience.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Nice To Haves

• Expertise in and experience with the development of biologics and/or biosimilars, especially drug substance manufacturing, upstream and downstream process development, and characterization, are highly preferred.

Responsibilities

• Contribute to regulatory strategy in new projects and portfolio.
• Provide regulatory guidance and advice to partners in development, technology transfer and manufacturing
• Manage the regulatory aspects of products and projects, including achievement of timelines and deliverables to align with corporate and departmental goals.
• Prepare, review communication documents & submissions to the agencies, including controlled correspondence, NDAs, ANDAs, BIA, BPD2/3, BLAs, etc.
• Work and address complex and technical issues with solid scientific rationalization.
• Identify and act on issues and risks from a regulatory perspective, especially for complex generics.
• Provide due diligence and review documents from domestic and international partners for technical and regulatory compliance.
• Provide regulatory assessments to the company (internal and partners), including change controls and/or document changes based on ICH and FDA guidelines.
• Represent the regulatory function on cross-functional developmental teams primarily with Operation, Quality, Legal and Marketing groups.
• Track and interpret FDA new guidances & new requirements, and assess their impact on product development, including expertise, timeline and budgeting.
• Support business development efforts
• Track deficiency trends, develop proactive and/or mitigation measures accordingly
• Provide training on regulatory sciences within Regulatory Affairs department and cross-functions.

Benefits

• Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week.
• Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
• Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
• Professional Growth: We offer ample opportunities for professional development and career advancement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree