Our client, a global pharma company, are currently looking for an Associate Director (Regulatory Operations) to join their team based in Berkshire, UK.
Reporting to the Executive Director of Regulatory Affairs, you will be responsible for the complete preparation and management of the publishing and submission of regulatory authorities in the EU. You will also organise and coordinate submissions in line with internal and external SOPs and provide advice and guidance to internal colleagues on submission issues. In addition, as part of your role as Associate Director, you will assist colleagues in the US with posting clinical trial information on the internet.
- Preparation and management of the publishing, compilation and assembly of documents for various submissions.
- Advise on submission strategy and take part in regular meetings.
- Provide training to personnel and consultants on regulatory submission and review activities.
- Assist in the writing of the SOPs.
- Assist the US regulatory operations team as needed.
- Keep up to date with European guidelines.
- Communicate with outside consultants as required.
- Take part in regulatory department meetings to transmit knowledge and discuss issues that need Reg Ops attention.
To be considered for this Associate Director (Regulatory Operations) position, you must have the following qualifications and experience:
- Hands on experience with publishing/submissions in the pharmaceutical industry.
- Strong working knowledge of EU regulations.
- Electronic publishing experience – CoreDossier, Documentum, etc.
- Self sufficient.
- Excellent leadership skills.
- Good interpersonal skills.
For more information, or to apply for this Associate Director (Regulatory Operations) role, please contact Meera Pattni on 01438 743 047 or email firstname.lastname@example.org.
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