Regulatory Affairs Manager
- Regulatory Affairs
Regulatory Affairs Manager- Permanent-
South West of Hertfordshire, UK
Extremely competitive salary and benefits package
Reference number- JO-1812-421009
A requirement for a Regulatory Affairs manager has come up, to join an innovative Regulatory consultancy with a dominance and a proven track record of success within the Lifesciences sector, particularly specialising in Pharmaceuticals and Medical Technology.
The role will require you to come onboard and manage a small team and assign new business to the team.
Coming from a strong Regulatory background, you will be expected to:
- Establish and maintain strong working relationships with new and existing clients
- Provide consultative strategic advice to guide product development and product launch efficiently
- Line manage a small team of Regulatory consultants, providing coaching and development where necessary.
- Allocate projects to specific team members, depending on availability and project complexity.
- Write and submit regulatory applications including Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), Post approval submissions.
- Have ownership of the full lifecycle management.
- Author briefing documents and participate in scientific advice meetings.
As a successful applicant, you must have:
- In-depth knowledge of EU and National regulations with a track record of successful submissions.
- Willingness to develop line management skills.
- Extensive experience in full life cycle management
- Ability to meet business requirements in a Pharmaceutical company.
- Scientific degree or equivalent
If this role is of interest to you, and you would like to have a confidential more in depth chat regarding the position then please give me a call on 01189522797.
Alternatively, feel free to email me your CV to firstname.lastname@example.org for immediate consideration.
If this role is not quite right, no worries at all. If youre interested in hearing about other great career opportunities, then please still get in touch as there are numerous Regulatory requirements at the moment. Additionally, if you know someone that may be interested in this role then we reward 250 worth of vouchers for every successful placement so please let me know!