Regulatory Affairs Specialist - Pharmaceuticals - Netherlands

REGULATORY AFFAIRS SPECIALIST/BREDA, NETHERLANDS/5 MONTHS CONTRACT/55 TO 88 EUR (PER HOUR)

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. C
- 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.
- 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.
- Be able to demonstrate driving partnerships within the industry.
- Experience within a clinical trial programme environment.
- 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.
- Excellent attention to detail.
- Degree or equivalent in a Life Science.
- Excellent communicator, both verbal and written.
- More than excellent command of English.

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.