Meera Pattni at CK Clinical is recruiting for a Global Regulatory Affairs CMC Associate to join a successful and innovative pharmaceutical company at their site in Yorkshire, UK.
The job:
As Global Regulatory Affairs CMC Associate, you will be required to assist the new product development and existing product development projects within the scope of the global regulatory CMC team. You will also assist and support regulatory CMC strategy and deliver submissions.
Responsibilities:
- Deliver global regulatory affairs CMC project activities by effective coordinator, strategy and implementation.
- Prepare and deliver regulatory submissions including CTAs, MAAs, INDs and variations/renewals in line with defined CMC plans.
- Work collaboratively with appropriate company personnel and contractors to coordinate the regulatory work stream elements for CMC activities.
- Liaise with regulatory authorities as required.
- Maintain documented regulatory project plans in line with best practice recommendations.
- Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the CMC team.
The ideal candidate:
Meera is looking for candidates will the following skills:
- Excellent communication skills.
- Highly organised.
- Ability to handle multiple projects at once.
- Results orientated.
- Strong negotiating and interpersonal skills.
- Openness to change.
How to apply:
For more information or to apply, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22877 in all correspondence.
