Manager of Regulatory Affairs, CMC & Regulatory Sciences

About Us:

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 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 among the top 100 Crain's Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for - Meitheal (Mee*hall): working together toward a common goal, for the greater good.

Position Summary:

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. S/he will work closely with the Regulatory management team, as well as other functions, to develop regulatory strategies for both projects and portfolios, with the goal of supporting the company's growth and transformation into a biopharmaceutical product portfolio.

Why Work with Us?

* 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.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• 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, FDA meeting packages (Pre-ANDA, Pre-IND, BIA, BPD2/3/4, etc.), and submissions (IND, NDAs, ANDAs, BLA).
• 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 and biosimilars.
• 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 the Operations, Quality, Legal and Marketing teams.
• 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 and develop proactive and/or mitigation measures accordingly.

Supervisory

No direct report.

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

Bachelor's or master's degree in life sciences and over 5 years related experience in product development and/or regulatory CMC, or equivalent combination of skills and experience.

Preferred

Expertise in and experience with development of complex /peptide/combination generics and/or biosimilars are highly preferred.

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. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Travel

No travel 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.