Junior Regulatory Affairs Specialist (German and English)

Randstad Professionals is actively looking for a German and English speaking Junior Regulatory Affairs Specialist to join their Medical Device client in Zuchwil, Switzerland.

General Job Description

-Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any critical regulatory documentation of specified regulatory submissions.

Responsibilities:

-Ensuring that the company's products comply with the regulations of government agencies.
-Keeping abreast of international legislation, guidelines and customer practices.
-Collecting and collating a wide range of information.
-Keeping up to date with a company's product range.
-Developing and writing clear arguments and explanations for new product licenses and license renewals.
-Preparing submissions of license variations and renewals.
-Setting timelines for license variations and renewal approvals.
-Understanding and evaluating complex information. § Working with specialist computer software and resources.
-Writing clear, accessible product labels and patient information leaflets.
-Planning and developing product trials.
-Interpreting trial data.
-Advising scientists and manufacturers on regulatory requirements.
-Resolving complex issues as they arise. § Preparing and coordinating documentation.
-Project managing teams of colleagues involved with the development of new products.
-Maintaining quality systems.
-Undertaking and managing regulatory inspections.
-Reviewing company practices and providing advice on changes to systems.
-Liaising with, and making presentations to, regulatory authorities.
-Submitting license and clinical trials applications to authorities to strict deadlines.
-Negotiating with regulatory authorities for marketing authorization.
-Specifying storage, labelling and packaging requirements.
-Liaising closely with the regulatory authorities on a regular basis.

Requirements:

-Proven expertise of Pharmaceutical Regulatory Affairs on an international basis.
-Business development skill sets with exposure to or having worked in a regulatory consultancy model. -Proven ability of interpreting legislation and impact to meet commercial needs.
-Proven capability of successful working relationships with regulatory bodies.
-Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions.
-Excellent communication and interpersonal skills, ability to influence.
-Proven success at managing and driving a team to meet strategic goals and KPIs.
-Creative and innovative, embraces the new.
-Demonstrate consequential thinking.

Languages: German and English (spoken and written)

If you're up for a new project, don't hesitate to send in your application.

Good to know you!

Charlotte