Associate Director of Regulatory Affairs, Biopharma

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:

The Associate Director of Regulatory Affairs, Biopharma, will be responsible for providing regulatory guidance to (Bio)Pharma product development and tech transfer, especially biosimilars, preparing and reviewing meeting packages and submissions. S/he will work closely with cross-functional teams within the Company and across business partners, including development, regulatory, clinical and quality, as well as the senior leadership team, to develop regulatory strategies for both 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 towards biopharmaceuticals.

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:

• Understand US regulatory guidance on biologics/biosimilars, track and interpret new guidance & new requirements for biosimilars, and assess their impact on product development, including expertise, timeline, and budgeting.
• Represent the regulatory function on cross-functional developmental teams for biosimilars, primarily with the Operations, Quality, Legal, and Marketing teams.
• Prepare and review meeting packages and submissions, including BIA, BPD, INDs, BLAs, etc.
• Serve as an interface with other regulatory groups in development, clinical partners, and consulting services.
• Lead preparation and management of meetings with health authorities, such as US FDA and EMA.
• Contribute to launch readiness and marketing by guiding the project team on the most appropriate regulatory approach, from development through approval, and provide post-market support.
• Provide due diligence and review documents from global business partners for technical and regulatory compliance.
• Work with the Head of Regulatory Affairs department to build up the competence and capacity for biosimilars and biologics.
• Provide training on CMC and regulatory sciences for biologics and biosimilars within the RA department and cross-functions. Provide support to CMC and regulatory sciences of complex generics, especially peptide generics, as well as combination products.

Supervisory:

No direct report.

Competencies:

• Planning and Organizing
• Teamwork
• Problem Solving
• Quality
• Judgment
• 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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

Bachelor, Master, or Ph.D. degree in life sciences; over 8 years related experience in product development and/or regulatory CMC, with a minimum of 3 years in biologics and/or biosimilars, or equivalent combination of skills and experience.

Preferred:

Expertise in and experience with Regulatory Affairs of biosimilars or biologics is 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:

Occasional travel expected (<10%).

Computer Skills:

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

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.