Associate Director, Regulatory Affairs Strategy EMEAC

Associate Director, Regulatory Affairs Strategy EMEAC

Pay Competitive

Employment type Full-Time

Job Description

Req#: ASSOC001754

Join Us | Reata Pharmaceuticals

As a commercial pharmaceutical company, we are committed to positively impacting the lives of patients with life-threatening diseases. With rigorous science and research as our foundation, we are a diverse team of problem solvers, trailblazers, and people who want to make a difference in the lives of patients. Having received our first drug approval in the U.S., we are focused on global expansion. In 2021, we established our European regional office in Zug, Switzerland.

What You Will Do | Responsibilities

The Associate Director, Regulatory Affairs Strategy EMEAC will lead all the relevant regulatory activities related to the development, registration and maintenance of Reata’s product portfolio across the EMEAC region. This role will support the development of regulatory product strategy and ensures the timely and high-quality execution of the EMEA regulatory strategy.

Key Responsibilities

• Participate in the development of regulatory strategies and tactical plans for the assigned products in collaboration with cross-functional teams
• Work closely with the GRL and departments area Operations, Submission Management, CMC, and Commercial Support) and be an active member of the global regulatory sub team providing regional input to global regulatory strategies
• Lead the preparation and timely submission of high-quality regulatory dossiers (scientific advice requests, orphan medicinal product designation applications, pediatric investigational plans, MAAs, variations and responses to HA questions) ensuring compliance with regulatory requirements
• Be a member of clinical trial teams and coordinates CTA related activities
• Ensure effective coordination of the interactions with the European Medicinal Agency (EMA), and National Regulatory Health Authorities
• Make sure that relevant internal teams, at global and EMEAC level, are kept updated in a timely manner, on regulatory product plans, progress and operational issues
• Provide support to local regulatory teams or external partners as applicable to meet local regulatory requirements
• Guarantee compliance with EMEAC regulatory requirements for assigned projects.
• Review of promotional materials of assigned products as required


What We Are Looking For | Qualifications

• Experienced professional with a minimum of 8 years of relevant experience and a proven track record of EU (EMA and EU country-specific competent health authority) regulatory submissions
• Recent hands-on experience with the planning and submission of CTAs and MAAs in electronic format
• Experience leading or participating in regulatory agency interactions
• Must have solid foundation in science obtained through academics and business experience
• Must be a strong team player, a fully engaged, hands-on professional capable of working collaboratively and independently, with excellent verbal and written communication skills
• Strong knowledge of EU Directives and guidance documents pertaining to pharmaceutical drug development, including knowledge of evolving global requirements for electronic filing of regulatory submissions


What We Are Looking For | Education

• University Degree in Pharmacy or similar


Location | Travel

• Based in Zug, Switzerland, 2-3 days on-site with flexible hybrid work arrangements
• Willingness to travel occasionally, as the business requires


Reata Rewards for You | Benefits

• Generous Total Rewards Plan
• Diverse and inclusive community focused on innovation, research and teamwork
• Many opportunities for growth and development in a fast-paced high-growth scale-up environment


Become a trailblazer | Make a difference | www.ReataPharma.com

Reata Pharmaceuticals is an equal opportunity employer committed to creating an inclusive environment for all employees.

About the company

Reata Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on identifying, developing and commercializing product candidates that modulate the activity of regulatory proteins involved in the biology of mitochondri...