Senior Regulatory Affairs Consultant– API / APAC Focus …, Basel

To strengthen our growing Regulatory Affairs consulting business, the Entourage team in Switzerland is looking for an experienced Senior Regulatory Affairs Consultant with strong expertise in pharmaceutical APIs and international regulatory environments, particularly APAC (China).

Additional experience in IVD Regulatory Affairs would be a strong advantage. We are looking for a hands‑on RA all‑rounder – from strategy to execution - with the ability to quickly adapt to new environments, work cross‑functionally, and ensure operational stability during critical project phases.

Your Responsibilities

Manage and maintain DMFs, ASMFs, CEPs, and related CMC documentation

Support global submissions, renewals, variations, and lifecycle management activities

Coordinate eCTD publishing activities and external publishing providers

Maintain regulatory databases, registration trackers, and product overviews

Assess regulatory changes and support change control activities

Act as RA contact for authorities, notified bodies, customers, and internal stakeholders

Identify and escalate regulatory risks where required

Lead or support cross‑functional regulatory projects and operational initiatives

Contribute to the improvement of internal regulatory processes, standards, and training programs

IVD-specific tasks (nice to have)

Preparation and maintenance of IVD Technical Documentation

Support UDI/EUDAMED activities and performance documentation

Temporary PRRC responsibility, if required

Your Profile

Several years of hands‑on experience in Regulatory Affairs within pharma, biotech, or life sciences

Strong expertise in API Regulatory Affairs and international submissions

Experience with APAC regulatory environments, particularly China, is mandatory

Practical experience with DMFs, ASMFs, CEPs, eCTD submissions, and lifecycle management

Pragmatic, operational, and solution‑oriented working style

Ability to work independently and in cross‑functional environments

Experience in GMP‑regulated industries is essential

IVD Regulatory Affairs experience is considered a strong plus

Fluent English required; German considered an advantage; Mandarin would be a plus

What You Can Expect

Exciting consulting projects in regulated life sciences industries

Long‑term project perspective with additional opportunities within a highly growing RA consulting environment

High level of responsibility and direct customer interaction

Entrepreneurial, flexible, and dynamic working environment with short decision‑making paths

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