Senior Regulatory Specialist – PPP Regulatory Affairs

Senior Regulatory Specialist – PPP Regulatory Affairs

Very competitive

Description

An opportunity to join the Regulatory Affairs team at an R&D focused global PPP company. You will manage a portfolio of plant protection products in specific geographical territories, develop regulatory strategy, and become the subject matter expert on the regulations/guidelines in your territory.

As a Regulatory Specialist, you will develop regulatory strategy for the product portfolio in your territory, prepare/review regulatory submissions, work with the in-house regulatory science team’s experts to produce technical dossier sections and risk assessments, submit regulatory applications, manage registration project costs and timelines, and monitor the progress of the regulator evaluations. You will be the lead contact with regulators in your region, track regulatory developments in your territory, and be the go-to person on those national guidelines.

We are looking for a Regulatory Affairs Specialist with a solid understanding of PPP regulations (EC No 1107/2009), project management skills, excellent organization, and strong written and verbal communication abilities, along with the capacity to present clear and concise argumentation to support regulatory or scientific positions. You may have a background in consultancy or another PPP manufacturing company; you could be a country regulatory manager, project manager, or a technical specialist looking to move into a more strategic position.

Key Skills

Regulatory Affairs, regulatory submissions, country regulatory management, plant protection products, crop protection, EU 1107/2009, project management, regulator contact, subject matter expert on national guidelines, registration strategy, budget management, managing deliverables.