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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.
This role can be home or office based in various Eruopean locations.
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
At least 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 experience with small molecule investigational products, including oral solid dosage forms (experience with sterile, topicals, semi-solid, or combination products is a plus!) OR previous experience with biologic investigational products.
Broad background in registration experience gained from working in the pharmaceutical industry or a regulatory authority.
Experience with EU submissions via the Centralised Procedure and national procedures.
Experience with extension applications for new strengths and / or pharmaceutical dosage forms.
Robust experience in preparing documentation for type I & II Quality post-approval variations.
Experience supporting the preparation of CMC documentation for IMPDs and new product EU MAAs would be advantageous.
Direct agency interactions and preparation of scientific advice briefing documents for CMC-related content and / or questions would be an advantage.
Ability to work independently and within project teams or committees, demonstrating accountability in achieving group goals and key project milestones.
Demonstrated competency in planning, project management, and tracking high complexity projects with clearly defined critical paths.
Fluent in English written and spoken
This role may require occasional travel to client locations (less than 15%) in the future as needed.
