Regulatory Consultant Job – Permanent – Surrey, UK
As Regulatory Consultant you will be required to represent the team on one or more therapeutic areas, as well as support senior scientists on product team. You will also be required to provide advice to team members to ensure appropriate labelling, regulatory strategy and high quality dossiers. You will also support clinical trial application in Europe.
- Establish and maintain quality files, both electronic and paper for quick easy access in accordance with internal procedures.
- Liaise with affiliates to anticipate country specific issues.
- Keep team members up to date on relevant submission issues.
- Develop strong expertise on European registration procedures and relevant guidelines.
- Establish and maintain contacts with other project team members.
- Lead small submissions, write and review regulatory documents.
- Help develop regulatory strategy for submissions and extensions.
- Establish regulatory timeline.
- Understanding of the drug development process.
- Experience with CTA documents.
- Experience within regulatory affairs essential.
- Knowledge of EU regulations and procedures.
- Excellent problem solving skills.
- Strong interpersonal skills.
For more information or to apply for this Regulatory Consultant position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email firstname.lastname@example.org. Entitlement to work in the EEA is essential. Please quote reference CL21278 in all correspondence.
Regulatory Conformance Officer Job – Durham, UK
Provide regulatory conformance expertise to ensure products comply with the registered requirements of the markets.
- Specify and gather information for the support of regulatory submissions.
- Find information to satisfy regulatory challenges to site product compliance.
- Assess the regulatory imapct of site requests for change ensuring compliance for batch release against registered details.
- Respond to questions from regulatory authorities raised during technical review of submissions, variations and renewals.
- Approve input to regulatory submissions in accordance with company policies.
- Review and approve site documentation.
- Ensure all work complies with GxP and health and safety requirements.
- Knowledge of GMP, CFR, FDA, MHRA and other regulatory requirements. Understanding of new business applications and new product introductions.
- Ability to manage conflicting prorities through liaison with key stakeholders and schedules.
- Life sciences degree.
For more information or to apply for this Regulatory Consultant position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email email@example.com. Entitlement to work in the EEA is essential.