Drug Regulatory Affairs Partner (temporary contract)
Share
Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
Roche Pharmaceuticals A/S is looking for a committed and energetic Drug Regulatory Affairs Partner with a structured and quality-oriented mindset for a Maternity Cover.
We offer a challenging and varied job in an active and flexible working environment where you will have independent responsibility for driving regulatory tasks and making an impact for our business. As a Drug Regulatory Affairs Partner you will be part of a small team of dedicated regulatory QA and compliance employees who work in a self-managed team with regulatory GxP and compliance tasks often with short deadlines.
The Opportunity:
Being regulatory responsible for assigned products in Denmark and Iceland.
Coordination and preparation of document packages for regulatory submissions for new products and Life Cycle Management submissions to registered products.
Proof reading of regulatory texts in local language.
Responsible for artworks changes related to Lifecycle Management this includes initiating manuscript creation proofreading and approval of artworks.
Make sure corporate regulatory data and document management systems are up to date.
Keeps abreast of regulatory legislations procedures and changes to the regulatory landscape to secure compliance at all times.
Have direct interaction with regulatory agencies.
Actively interact and support the business and disease area teams with regulatory details timelines and information related to products to support business and launch activities.
Work with the Roche HQ to coordinate and support Scientific Advises with the Danish Health Authorities where Denmark acts as Rapporteur Country for EMA.
Responsible for implementing new systems and training new colleagues.
Maintenance of procedures to secure compliance to regulatory legislation.
Who you are
You have a masters degree in pharmacy pharmaceutical sciences or a related field.
Have a strong personality and thrive to work in a regulated area
You are systematic in your way of working you are flexible and you have strong interpersonal skills
You are a team player that can work both independently and cooperate effectively with others.
You are able to communicate and express yourself fluently in Danish and English both spoken and written.
You are welcome to contact Sandra Stendal Head of License to Operate and Business Enabling onfor further information.
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.
