Meera Pattni is currently looking for a Regulatory Affairs Project Manager to join a Development Partnering Organisation to join their European office which is based in Central London.
This Development Partnering Organisation act as virtual partners in supporting its Biotechnology and Pharmaceutical clients throughout the entire clinical research, development and submission process.
The main responsibilities of this Regulatory Affairs Project Manager position include:
- Conducting regulatory reviews of technical summaries, clinical study reports and administrative documents forregulatory filings.
- Assisting with the filings and approval processes for MAA products within all types of European procedures.
- Assisting with regulatory submissions outside of EU authorities including Switzerland, South Africa and Australia.
- Assisting with providing regulatory expertise on MA life cycle management – variations, renewals, labelling and line extensions.
- Ensuring submissions adhere to EU and ICH guidelines.
- Ensuring submission process and standards adhere to internal SOPs.
- Interacting with clients regarding regulatory issues.
- Conducting regulatory reviews for eCTD/electronic submission requirements.
The ideal candidate for this Regulatory Affairs Project Manager position will have the following skills, qualifications and experience:
- Minimum of a Bachelors degree in life sciences.
- Previous experience with regulatory submissions in the EU.
- Experience with eCTD.
- Proficiency in performing document reviews and quality assurance checks.
- Ability to manage multiple projects simultaneously.
- Prior experience communicating with external clients.
- Experience with Medical Devices combined with either drug or biologics preferable.
For more information or to apply for this Regulatory Affairs Project Manager position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email firstname.lastname@example.org. Please quote reference CL22236 in all correspondence.