Regulatory Affairs Consultant - CMC small molecule

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Parexel Consulting is seeking a talented and experienced CMC Regulatory Affairs Professional to join our team as a Regulatory Affairs Consultant. In this role, you will have the opportunity to utilize your expertise in CMC, exceptional communication skills, and strong writing experience, contributing to our clients' success in the pharmaceutical industry. This position offers exposure to novel technologies and a wide range of responsibilities, from clinical trials to post approval and maintenance.

As the Regulatory Affairs Consultant, you will collaborate closely with a multinational pharmaceutical company, ensuring the effective planning, review, and preparation of CMC components for investigational new drugs, new drug license applications, progress reports, amendments, supplemental applications, and maintenance of approved marketed products.

Your key responsibilities will include:

• Assisting in the technical review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.
• Ensuring that documents meet established regulatory requirements in terms of content and structure.
• Serving as a liaison between various functional groups, program teams, international regulatory bodies, and business partners, proposing solutions based on your technical experience and identifying potential project timeline delays.
• Maintaining Regulatory CMC documentation.
• Managing related databases and submission schedules.
• Assisting in the development of submission plans and project timelines.
• Preparing for and interacting with regulatory agencies during drug submissions, responding to inquiries, and participating in regulatory agency inspections.

Skills and Experience required for the role:

• University degree in a scientific field.
• 3-5 years of relevant experience in the pharmaceutical industry or a regulatory authority.
• Successful experience in delivering CMC sections of marketing authorizations, investigational drugs, and life cycle management of commercial products.
• Knowledge of EMA guidance, regulations, and ICH/GMP requirements.
• Previous regulatory experience with small molecule.
• Experience with EU submissions via the Centralised Procedure and national procedures.
• Experience with extension applications for new strengths and/or pharmaceutical dosage forms.
• Experience supporting the preparation of CMC documentation for IMPDs and new product EU MAAs would be advantageous.
• Ability to work independently and within project teams or committees, demonstrating accountability in achieving group goals and key project milestones.
• Fluent in English written and spoken.