Pharmaceutical Regulations Consultant
1 week ago
Parexel Consulting seeks a seasoned Regulatory Affairs Consultant to collaborate with our team.
">About the Position:
">We require an experienced professional with expertise in Clinical Trial Management and strong communication skills to contribute to the success of our clients 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.
This role involves working 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:
">- ">
- Providing technical support in the review and preparation of investigational drug applications, marketing applications, and other reports for submission to regulatory agencies.">
- Verifying that documents comply with established regulatory requirements in terms of content and structure.">
- Coordinating with various functional groups, program teams, international regulatory bodies, and business partners, offering solutions based on your technical expertise and identifying potential project timeline delays.">
- Ensuring the accuracy and completeness of Regulatory CMC documentation.">
- Managing related databases and submission schedules.">
- Contributing to the development of submission plans and project timelines.">
- Participating in regulatory agency inspections and responding to inquiries.">
About You:
">We are seeking a candidate with a university degree in a scientific field and at least 5 years of relevant experience in the pharmaceutical industry or a regulatory authority. Your experience in delivering CMC sections of marketing authorizations, investigational drugs, and life cycle management of commercial products is essential.
">You should have knowledge of EMA guidance, regulations, and ICH/GMP requirements. Previous regulatory experience with small molecule and EU submissions via the Centralised Procedure and national procedures is also required.
">Benefits:
">We offer a competitive salary of €60,000 per annum, a comprehensive benefits package, and opportunities for professional growth and development.
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