Regulatory Affairs Manager CMC

Galderma Uppsala is expanding the Medical Device Regulatory Affairs Team and we are looking for a Regulatory Affairs Manager CMC (Chemistry, Manufacturing and Control) to join us.



The role focuses on the regulatory aspects of Chemistry, Manufacturing and Control (CMC) for Galderma's Aesthetic portfolio. You will be working with brands like Sculptra and Restylane



As Regulatory Affairs Manager CMC you will represent Regulatory Affairs in development and life cycle management activities, with a focus on the CMC aspects of the product registrations. The role includes ensuring post-approval regulatory compliance and you will be accountable for assessing the regulatory impact of product/process improvements. You will be involved in scientific writing and submissions to authorities. You will act as the regulatory subject matter expert and provide guidance to projects and organization teams.



Key tasks:



· Provide regulatory CMC guidance in R&D and Manufacturing projects, improvements, and line related activities

· Develop regulatory CMC strategies for marketing applications worldwide

· Assess the regulatory impact of product and process changes/improvements to ensure compliance

· Scientific writing for regulatory submissions worldwide

· Coordinate regulatory submissions to authorities

· Keep updated on changes to regulatory requirements and inform the team.

Contacts with regulatory bodies, affiliates, partners and consultants



Skills & Qualifications:



· At least a BSc in Life Sciences or Engineering.

· Regulatory affairs experience with medical devices or pharmaceuticals , specific experience with CMC is a merit

· Professional level Swedish and English



What Galderma offers:



You will be working with a global dermatology company with operations in 90 countries. The Uppsala site is Galderma's global center for our aesthetics business and has operations in product development, manufacturing and marketing. We offer an opportunity to work in a dynamic and international environment where personal and professional development is encouraged. We are located along the river Fyrisån, 10 minutes by bike from Uppsala Central Station.



Your application



We welcome your application (CV and letter) via our company website CAREERS | Galderma



Apply as soon as possible though no later than the 11th of December 2022. The selection process is ongoing and the role may be filled prior the last application date.