Senior Regulatory Affairs Associate & Medical Advisor

Research & Development
📅



Thu 18 Apr 15:51
Post Date
📅



1004
Total Views
Thanks for your interest in the Senior Regulatory Affairs Associate & Medical Advisor (DACH) position. Unfortunately this position has been closed but you can search our 0 open jobs by

.

A fantastic opportunity for a Senior Regulatory Affairs Associate & Medical Advisor to join RB's Health Business Unit.

As a member of the Regulatory & Medical Affairs department, you will be t
aking Regulatory responsibility for one or more Healthcare brands comprising Medicinal Products, Cosmetics and/or Medical Devices in Germany, Austria and Switzerland.

Key parts of this role will include:

• Assessing Regulatory strategies
• Providing Regulatory input into portfolio discussion and pipeline discussion
• Filing and following up of applications for MAs, variations, PSURs and other regulatory actions, ensuring timelines are kept
• Being responsible for Artwork, PR-texts and copy approval from Regulatory perspective including recommendation for further improvement
• Participating actively in life cycle management considering regulatory and business needs while paying attention to cost aspects
• Ensuring a smooth running of the business while actively preventing interruption due to regulatory malfunctions
• Supporting the development of Regulatory claims
• Brand development and development of BDI initiatives from Regulatory Affairs perspective
• Assessing launch plans to check if products fit into PC legislation and advising on alternative strategies if necessary
• Artwork and Copy approval from Regulatory perspective including artwork and product improvement initiatives
• Enhancing Regulatory knowledge within the team by providing learnings and trainings from own projects which are applicable to other brands
• Answering medical questions raised by consumers and HCPs
• Supporting Key Opinion Leader management
• Providing medical support for Marketing Authorisation Applications and variations (e.g. SPC, M5)
• Collaborating with Global Clinical Department in planning PMSS and clinical trials

Is this you?

Degree in natural sciences, ideally in Pharmacy or Medicine. PhD and/or Master in Drug Regulatory Affairs would be nice to have
2-4 years in Drug Regulatory Affairs preferably for OTC products
Experience in all types of application for Marketing Authorisations and in
Licence Maintenance & Life Cycle Management
Deep understanding of pharmaceutical, non-clinical and clinical aspects of OTC products
Experienced with all standard IS applications (MS-Office etc.)
Following rules & legislations as well as internal procedures
People management skills in the scope of project management
Very good communication skills (in order to transfer regulatory knowledge to non-regulatory audience)
Fluent in English
Fluent in German (native level speaker)

Admission procedures would be nice to have:
MRP (Mutual Recognition Procedure) /DCP (Decentralised Procedure) /National Applications
Variations
Experience in Regulatory Affairs for Personal Care products
Experience in Medical Device regulations
Experience with other types of products like Medical devices, Personal care products

In return, RB offers very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.

mehr...

zur Vakanz

Weitere Jobs von Closed