Sr. Manager, Regulatory Affairs - CMC & Reg. Sciences

About Us:

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 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.

The estimated salary range for this position is $120,000 to $155,000.

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.

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 employer contribution

* Competitive PTO and company-paid holidays

* Paid parental leave (maternity & paternity)

* Onsite gym

* Hybrid work schedule

Position Summary:

The Senior Manager, 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 of biosimilars. S/he will work closely with the management team of Regulatory department to develop regulatory strategies for projects and portfolios, contributing to the transformation and growth of regulatory team to meet the needs of company's business growth of biopharmaceuticals.

Essential Duties and Responsibilities; other duties may be assigned.

* Contribute to regulatory strategy in new projects and our 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 and review communication documents & submissions to the agencies, including IND, BIA, BPD2/4, BLAs, etc.

* Work and address complex and technical issues with solid scientific rationalization.

* Identify and act on issues and risks from a regulatory perspective.

* 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 guidance & new requirements and assess their impact on product development, including expertise required, timeline, and budgeting.

* Support business development efforts.

* Track deficiency trends and develop proactive and/or mitigation measures accordingly.

* Provide training on regulatory sciences within RA department and cross-functions.

Supervisory Responsibility - None

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.

Education and/or Experience

Master's or Ph.D. degree in life sciences; over 5 years related experience in product development and/or regulatory CMC or equivalent combination of education and experience. Expertise in and experience with complex /combination generics (peptides), biologics and/or biosimilars are highly preferred.

Communication Skills

Ability to author 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 read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. 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 - Not expected

Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems (DocuBridge).

Equal Opportunity Employer:

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