Senior Director of Regulatory Affairs
1 week ago
Description
Company Overview:
Established in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a dynamic company dedicated to the development and commercialization of generic injectables. With a recent expansion into fertility, biologics, and biosimilars, Meitheal markets over 50 FDA-approved products across various therapeutic areas. Committed to accessibility and affordability, Meitheal exemplifies the Irish guiding principle of "Meitheal," fostering teamwork toward common goals.
Job Summary:
The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. This role involves preparing and reviewing submissions and working closely with cross-functional teams within the company and across business partners. The successful candidate will develop regulatory strategies for projects and portfolios in BioPharma, contributing to the transformation and growth of the regulatory team to meet the company's business growth towards biopharmaceuticals.
Essential Duties and Responsibilities:
- Thoroughly understand US regulatory guidance on biosimilars; track and interpret new guidance and requirements, assessing their impact on product development.
- Represent the regulatory function on cross-functional developmental teams for biosimilars, collaborating with Operations, Quality, Legal, and Marketing groups.
- Prepare and review meeting packages and submissions, including BIA, BPD, INDs, BLAs, etc.
- Serve as an interface with other regulatory groups in development, manufacturing, clinical partners, and consulting services.
- Lead preparation and management of meetings with health authorities, such as US FDA, EMA.
- Guide the project team on the most appropriate regulatory approach from development through approval and provide post-market support.
- Conduct due diligence and review documents from global business partners for technical and regulatory compliance.
- Collaborate with the Head of Regulatory Affairs to build 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.
- Support CMC and regulatory sciences of complex generics, especially peptide generics.
Supervisory Responsibilities:
- Supervise 1-3 direct reports.
Qualifications:
- Bachelor’s, Master’s, or Ph.D. degree in life sciences.
- Over 8 years of related experience in product development and/or regulatory CMC, with a minimum of 3 years in biologics and/or biosimilars.
- Expertise in and experience with Regulatory Affairs of biosimilars are highly preferred.
Skills:
- Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Effective communication skills, both written and verbal.
- Mathematical Skills: Proficiency in mathematical concepts such as probability, statistical inference, and fundamentals of geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Reasoning Ability: Strong problem-solving skills and the ability to deal with a variety of concrete variables in situations where limited standardization exists. Capability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Travel:
- Occasional travel expected (
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