Regulatory Affairs Manager
Oliver Care at CK Clinical is recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in Hertfordshire on a permanent basis.
The main purpose of the role will be to:
- Apply a broad knowledge and interpretation of regulatory requirements in Emerging Markets to enable efficient and effective registration of medicinal products and ensure that regulatory documentation meets relevant regulatory requirements and Eisai quality standards.
- Contribute to the development and implementation of regulatory strategy for own functional area/region and participate in issue resolution by escalation and monitoring regulatory risks.
- Compile regulatory documentation and oversee regulatory submission activities within defined timeframes and in line with defined standards and protocols and provide regulatory support to teams for allocated projects.
Further responsibilities will include:
- Developing an understanding of the importance of lifecycle management and how key regulatory strategies and activities can fulfil commercial needs and maximise assets.
- Assisting functional lead interactions with regulatory authorities but gathering and communicating relevant information to/from the project team and begin to manage routing communications under functional lead supervision as well as possibly participating in phone or in-person meetings.
- Managing the workflow of others to ensure deadlines are met and may manage contractors, ensuring that their work is completed to agreed timelines. You may also assist or lead the training of junior staff.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level above in the life sciences or a related field with experience with regulatory methods and processes in an industry setting.
- Previous experience of developing regulatory strategies for NDAs/MAAs or significant line extensions.
- Have cultural awareness, experience with working with colleagues from different cultural backgrounds and the ability to undertake long distance travel- some of which may be at weekends.
This is an excellent opportunity to join a global pharmaceutical company developing high quality products across the world and it also offers an attractive benefits package.
For more information or to apply for this position, please contact Oliver Care on 01438 842976 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL31346 in all correspondence.