RegCMC Senior Manager

A leading global pharmaceutical company that specialise in the development of biological therapies is advertising a vacancy for a RegCMC Senior Manager position. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas. Based in Basel, this is an exciting opportunity to work with an internationally renowned establishment. This role will be a six-month contract position. Please note that the company is NOT looking for candidates with experience in Reg-CMC.

Job Responsibilities:

• Provide input into global regulatory strategy for early development compounds.
• Contribute to regulatory innovations (e.g. novel therapeutic approaches, indications, or endpoints, or any innovative regulatory pathways).
• Contribute to identification of regulatory issues, gaps, and trade-offs affecting optimal and timely submission and approval.
• You will be a key contributor in the core project Teams to the overall project development strategy.
• You will work in a high-performing multi-disciplinary Team to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator Brochures, end of trial notifications, submission of CSR etc.
• Participate in regulatory activities in planning early Health Authority (HA) interactions and in negotiations with HA to address queries on INDs and CTAs.

Skills and Requirements:

• A Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) is a plus.
• 2-4 years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge, and regulatory operational expertise of EU regulatory affairs. Additional knowledge of other regions is an asset.
• Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development, or other experimentally based discipline, as well as with biologics is an asset.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Patrick Hale at +44 203 826 1331 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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