Sr. Director, Regulatory Affairs - CMC & Reg. Sciences, Biopharma at Meitheal Pharmaceuticals Inc – Chicago, Illinois

ABOUT MEITHEAL PHARMACEUTICALS

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly-priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 in 2024 on Crain’s Fast 50 in Chicago, and in the top 100 of Crain’s Best Places to Work in Chicago from 2022 to 2025, Meitheal emulates the traditional Irish guiding principle we are named for — working together toward a common goal, for the greater good.

What We Offer

· Competitive pay and medical, dental, and vision insurance

· Flexible spending accounts

· Long- and short-term disability insurance, as well as life insurance

· 401(k) plan with match

· Competitive PTO and company-paid holidays

· Paid parental leave (maternity & paternity)

· Onsite gym

· Hybrid work schedule

The pay range for this position is $230,000.00 to $2900,000. Payrate is determined by considering a person's prior experience, skills and knowledge.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Summary

The Senior Director of Regulatory Affairs-CMC & Regulatory Sciences, Biopharma, will be responsible for managing regulatory CMC work for biopharmaceuticals (biologics and biosimilars). S/he will work closely with cross-functional teams within the Company and across business partners, as well as with the senior leadership team, to develop regulatory strategies for projects and portfolios in BioPharma, contributing to the transformation and growth of the regulatory team to meet the needs of the company's business growth toward biopharmaceuticals.

Job Responsibilities

Job responsibilities include the following: other duties may be assigned.

· Manage RA deliverables for biosimilar projects.

· Pursue regulatory excellence and optimize cross-functional/across-site work process in submissions for both quality and efficiency.

· Track and interpret new guidance and requirements for biosimilars and assess their impact on the new product submissions and approvals, including expertise, timeline and budgeting.

· Represent the regulatory function on cross-functional teams for biosimilars.

· Prepare, review meeting packages and submissions to US FDA, including BIA, BPD, INDs, BLAs, etc.

· Lead preparation and manage meetings with health authorities, such as US FDA.

· Serve as an interface with other partners, and consulting services.

· Contribute to the launch readiness and marketing by guiding the project team on the most appropriate regulatory approach towards approvals and provide post-market support.

· Provide due diligence and review documents from global business partners.

· Contribute to portfolio and pipeline selection and prioritization.

· Work closely with management team of regulatory affairs department to identify the gaps and build up competence and capacity for biosimilar and biologics.

· Provide training on CMC and regulatory sciences for biologics and biosimilar within RA department and cross-functions.

· Supervisory responsibilities: 2–5 direct reports

Competencies

· Planning and Organizing

· Teamwork

· Problem Solving

· Quality

· Judgement

· Dependability

· Strong Interpersonal Skills

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

Master or Ph.D.'s degree in life sciences; over 10 years related experience in pharmaceutical or biotech industry, in areas of development, regulatory strategy, and/or regulatory CMC, with minimum of 5 years in management/supervisory roles, or equivalent combination of education and experience. Expertise in and experience with biologics/biosimilars and/or combination products, human factor or clinical studies are highly preferred. Experience with multiple cultural, global working teams would be a plus.

Language Skills

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.

Mathematical Skills

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.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Travel

Occasional travel expected - less than 10%

Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC), etc.

AAP/EEO Statement

Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities.