Regulatory Affairs Manager - new products to be released 2018
NonStop's Client a global pharmaceutical client is searching for a regulatory affairs manager to support the regulatory actives for 3 new products to be released across Europe and the US in 2018 and following years.
As the RA manager you will be responsible for:
* Management of compliance with relevant regulatory legislation and guidelines
* Defining project and product regulatory strategy in line with commercial and company strategy, consulting with appropriate departments when necessary
* Liaising with regulatory authorities
* Provision of expert regulatory advice to other departments in the organisation, and regulatory support to licensing partners in the EU and other territories
* Ensure communication of changes in business-critical legislation/regulatory guidance, and project and product regulatory status to appropriate internal and external personnel in a timely manner
* Pro-actively identify potential obstacles to approval of regulatory submissions and manage the resolution of issues
* Regular contact with regulatory authorities and external consultants working on behalf of the company
* The ability to understand and present complex scientific arguments
In order to be successful within the position you should have:
* Expert Regulatory Affairs experience, preferably with orphan drugs in Europe and the US
* Excellent negotiation, verbal and written communication and interpersonal skills
* The ability to think strategically and develop global regulatory strategy whilst balancing local/affiliate needs
* Good analytical and problem solving skills
* Good organisational and project management skills and high attention to detail
This is an exciting time to join the business as they are in a period of growth, opening opportunities for career development.
The office is based around the Edinburgh area.
If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at email@example.com, or by calling me on 02079402105 for a discussion in confidence.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.