Regulatory Manager

Mandated by our client, we are looking for a Regulatory Manager. This person will be responsible for managing and coordinating regulatory and strategic activities to company submissions (Pharma and IVDD, IVDR). This position will report to Head of Quality & Regulatory.

Regulatory Manager

Your assignment

- Provide regulatory and strategic management to company submissions (Pharma and IVDD, IVDR)
- Liaison with Regulatory Authorities (EU, US, China, Japan)
- Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide
- Responsible for development and implementation of the Regulatory Strategy and Risk Documents
- Provide regulatory and strategic input on: development concepts and documents (e.g. dev plan, CTA/IND, briefing books, dossier documents); clinical study protocols and protocol amendments
- Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.
- Comply with applicable SOPs, GOPs and WIs

Your profile

- BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Alternatively several years of regulatory or other relevant industry experience
- Fluent English required (oral and written)
- At least 3 years of relevant regulatory experience in Pharma and /or IVD
- Good understanding of regulatory requirements for drug development and IVD, clinical studies, dossier filings worldwide
- Experience in HA negotiations in different regions (EU, US, China, Japan)
- Strong interpersonal skills, team player

   

Interested?

We look forward to receiving your application via the online application form.