Senior Regulatory Manager
- Regulatory Affairs
Senior Regulatory Affairs Manager
Home based UK
Excellent numeration package
Regulatory Professionals are currently working with an innovative pharmaceutical company with focus in Oncology. Their emphasis is within developing and marketing leading cancer drugs engaging in research, development and manufacturing.
Our client is looking to bring a Senior Regulatory Manager to the team to prepare and direct global regulatory strategy along with providing expertise during the drug development process.
Initiates interactions and negotiations directly with regulatory authorities during the drug development process
Conducts the regulatory activities to a high quality and ensure completeness of all projects, supporting CTA, MAA, IMPD and IND, NDA submissions.
Independently directs as well as prepares global regulatory strategy, with a strong focus on European regulatory affairs
Ensures collaboration and effective working relations with EMA and EU National Competent Authorities
Provides oversight to Contract Research Organisations in aspects of regulatory strategy and implementation.
Bachelors degree in pharmacy, biology, chemistry or related scientific discipline or equivalent experience is required.
Substantial knowledge and experience interacting and negotiating with regulatory agencies, particularly the EMA and National Competent Authorities.
Strong working knowledge of global regulatory requirements and submission processes.
Previous experience within Oncology would be highly advantageous
If you are interested in discussing this position further then please send your CV to firstname.lastname@example.org or if you have any questions regarding the role then please call 01189 522 797.
Please note you must be eligible to work in the UK to be considered for this role.
If this role is not quite right for you, but youre interested in hearing about new career opportunities, then please still get in touch as further Regulatory roles are available. Additionally, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if successfully placed youll receive 250 worth of vouchers.