About Us:
Founded in 2017 and headquartered in Chicago, Meitheal Pharmaceuticals is a trailblazing company committed to the development and commercialization of generic injectables. Recently, we've expanded into fertility, biologics and biosimilars, now marketing over 50 FDA-approved products across various therapeutic areas. We embody the Irish principle of "Meitheal," fostering teamwork toward common goals, ensuring accessibility and affordability for all.
Job Summary:
Associate Director of Regulatory Affairs, Combination Products, will be responsible for providing regulatory guidances to devices / combination product development and life cycle management, including generic products, 505B2 NDA products and biosimilars, preparing and reviewing submissions. You will work closely with cross-functional teams within the Company and across business partners and play a critical role in the transformation and growth of regulatory teams to meet the needs of the company’s business growth toward biopharmaceuticals.
Why Work with Us?
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Hybrid Work Schedule: Enjoy the flexibility to work remotely two days a week, balancing your professional and personal life.
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Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style.
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Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas.
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Professional Growth: We offer ample opportunities for professional development and career advancement.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following. Other duties may be assigned.
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Provide strategic regulatory guidance on combination products/devices to senior management and specific project teams.
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Work closely with cross-functional teams and external consultants to ensure regulatory compliance throughout device and/or combination product development.
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Proactively identify possible regulatory risk or issues and recommend mitigation measures or solutions.
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Prepare and participate FDA meetings and EMA Scientific Advisory meetings for device/combination product development (generic products, innovative (505B2) products, and biosimilars) . Prepare and review regulatory submissions to FDA, EMA, and other regulatory agencies.
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Work with Head of Regulatory Affairs department to build up the competence and capacity for combination products
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Provide support to CMC and regulatory sciences of complex generics, especially peptide generics, 505B2 NDA/innovative products, and biosimilars/biologics.
Supervisory
Competencies
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Planning and Organizing
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Teamwork
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Problem Solving
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Quality Judgement
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Dependability
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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
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Bachelor, Master, or Ph.D. 's degree in life sciences.
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5 + years related experience in product development and/or regulatory affairs.
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Minimum of 3 years in combination product area. Or equivalent combination of education and experience.
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Expertise in and experience with Regulatory Affairs of devices/drug-device combination products 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. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills
Microsoft Office, Adobe Systems (Pro, Acrobat DC), and Regulatory publishing systems (DocuBridge).
Benefits:
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Competitive salary and performance-based bonuses.
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Comprehensive health, dental, and vision insurance.
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Generous PTO and paid holidays.
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Retirement savings plan with company match.
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Professional development and training opportunities.
How to Apply:
Ready to join a company that values your expertise and offers a flexible and supportive work environment? Apply today to join the Meitheal team and contribute to our mission of fostering teamwork towards common goals.
Join us at Meitheal, where innovation meets flexibility. Let’s build the future together!
AAP/EEP
Equal Opportunity Employer Minorities/Women/Veterans/Disabled. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.