Regulatory Affairs Senior Manager OTC
Regulatory Affairs Manager / Senior Manager OTC, Consumer Health, contract job
Your new companyThis well known Consumer Health company is looking for an experienced Regulatory Affairs Manager / Senior Manager to join their established team. This is a 6-month contract job with scope for extension.
Your new role
The main responsibility of this job as Regulatory Affairs Manager / Senior Manager is the management of post-approval activities for specified OTC products.
You will support the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing procedures for CMC and non-CMC variation, when WS is appropriate and develop regulatory strategies, preparation of regulatory applications and support maintenance activities for MRP/DCP products
As Regulatory Affairs Manager OTC contract, you will support the team with regulatory activities for European procedures (Decentralised, Mutual Recognition, WS) as appropriate and play a key role in identifying regulatory activities to ensure all regulatory obligations and business objectives are met.
What you'll need to succeed
In order to be considered for this contract job as Regulatory Affairs Manager / Senior Manager OTC, you must have prior experience in preparing and compiling regulatory submissions (Variations, renewals, PSUSA etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines for OTC, Consumer Health products
What you'll get in returnFlexible working options are available.
What you need to do nowFor more information on this or any other Regulatory Affairs jobs within OTC, Consumer Health, Medical Devices or Cosmetics, please apply to this advert and ask for Victoria Dunlop.