Regulatory Operations Manager
- Experience Level
A rapidly growing speciality pharmaceutical company is seeking to recruit a Regulatory Operations Manager to their office in Hertfordshire. The organisation supplies medicines and medical devices across Europe and the US through direct sales. This vacancy is an exciting opportunity to work with an innovative company and provide expertise in eCTD publishing.
The Regulatory Operations Manager will be responsible for the creation and submission of all INDS / NDAs / MAAs & 510Ks. They will ensure publishing projects are delivered to high quality and on time. They will directly interface with customers to manage project aspects, e.g., validation queries, including issue resolution, and providing subject matter expertise for publishing related inquiries. They will also take ownership for compiling, tracking, dispatching, and archiving regulatory documents and submissions in both paper and electronic formats (eCTD and Nees).
- Formatting, publishing, performing QCs, and transmitting and archiving the regulatory submissions (eCTD and NeeS)
- Assisting the Regulatory Leads in drafting and preparing regulatory submission packages; this includes gathering necessary source documentation for regulatory filings and documenting them appropriately.
- Bookmarking and hyperlinking PDF documents to ensure adherence to guidelines for incorporation into submissions using PDF editing tools, including Adobe Acrobat Professional.
- Assisting the Regulatory Product Leads in gathering Regulatory documents and formatting to the necessary requirements.
- Keeping track of the publishing of regulatory submissions and providing updates to the team when necessary.
- Assembling and submitting regulatory submissions (in eCTD format). Ensure consistency, completeness, and adherence to Health Authority electronic submission standards for all regulatory submissions.
- Support larger submissions, such as CTAs and MAAs.
- Maintaining all Regulatory (EU/US and ROW) correspondences
- Supporting implementation, staff training and maintenance of the Company's Regulatory Information and Electronic Document Management Systems.
- Supporting additional activities in the team which will include administrative task.
- Maintaining an understanding of company Pharma working practices and SOPs and relevant country codes and ensuring these standards are met across the organisation.
Skills and Requirements:
- At least 5 years in a regulatory documentation environment, preferably in the pharma industry.
- Strong prior experience within regulatory operations and good knowledge of regulatory submissions throughout the medicinal product development as well as CTD format.
- Direct involvement in and knowledge of the preparation and filing of EU MAAs/BLAs/NDAs/INDs/CTAs and be familiar with CTD requirements and ICH guidelines.
- Ability to independently perform eCTD publishing tasks and manage the training and publishing activities of others.
- Knowledge of health authority procedures/guidance regarding electronic submissions.
- Strong experience with Electronic Document Management Systems (EDMS) and creating and compiling eCTD submissions in a publishing tool.
- Strong eCTD publishing experience.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joe Beddows at +44 203 854 2623 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.