Senior Director of Regulatory Affairs, Specialty Pharma
4 weeks ago
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:
Senior Director of Regulatory Affairs, Specialty Pharma, will be responsible for leading regulatory strategy for specialty pharma products, especially combination products in development and life cycle management, including A/NDA products and biosimilars. S/he will work closely with cross-functional teams within the Company and across business partners, to prepare, review and finalize regulatory submissions, and play a critical role in the transformation and growth of regulatory team to meet the needs of company's business growth toward biopharmaceuticals.
Why Work with Us?
- Hybrid Work Schedule: Enjoy the flexibility to work remotely two days a week, balancing your professional and personal life.
- 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:
- Provide strategic regulatory guidance on specialty pharma, especially combination products to senior management and specific project teams, from portfolio development, project execution to life cycle management.
- Work closely with cross-functional teams and external consultants to ensure regulatory compliance throughout combination product development.
- Proactively identify possible regulatory risk or issues and recommend mitigation measures or solutions.
- Prepare and participate in FDA meetings and EMA Scientific Advisory meetings for product development (Biosimilars, generic and innovative products), with focus on drug-device combination products.
- Prepare and review regulatory submissions and deficiency responses to FDA, EMA, and other regulatory agencies.
- Work with Head of Regulatory Affairs department to build up competence and capacity to enhance the efficiency and productivity of project execution as well as the approvability of submissions.
- Provide support to CMC and regulatory sciences of specialty pharma products, including biosimilars/biologics.
Qualifications:
Education and/or Experience
Bachelor, Master, or Ph.D. 's degree in life sciences. An advanced degree is preferred. Over 10 years related experience in product development and regulatory strategy, and/or regulatory affairs, with a minimum of 3 years in combination product area. Must have experience in preparing comprehensive packages for meetings with FDA and other regulatory agencies, developing regulatory strategies to streamline development process for efficiency and cost-effectiveness, as well as addressing challenges and deficiencies of technical complexity. Expertise in drug-device combination products, including peptides, biologics 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. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- Generous PTO and paid holidays.
- Retirement savings plan with company match.
- 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
Meitheal is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Requirements:-
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