Senior Regulatory Affairs Project Manager

Job Role:

• Maintain marketing authorisations in Europe through the Centralised, Mutual Recognition and Decentralised Procedures, including preparation and submission of documentation to regulatory agencies.
• Provide EU input to Global regulatory strategies to support LCM activities.
• Lead and/or participates in regulatory and cross-functional teams for assigned projects
• Direct and/or indirect liaison with Health Authorities (in conjunction with CRLs) to facilitate prompt review and approval of applications.
• Understand the regulatory environment and communicate priorities to global/regional stakeholders.

Role Responsibilities:

• Contribute to Global Regulatory Strategy Documents or create regional regulatory strategies, as necessary, for marketing authorisation LCM applications using EU procedures. Strategies should achieve the business objectives, have a high probability of being accepted by the regulatory agencies, minimise resource demands and aim to deliver approvals at a time acceptable to the commercial need.
• Coordinate the preparation of marketing authorisation LCM applications to regulatory agencies and responses to agency questions according to required timelines following procedures required under the relevant SOP(s).
• Ensure proposed updates are consistent with current approved dossier information and EU guidelines. Develop and maintain constructive working relationships with Health Authority contacts.
• Coordinate pre-submission meetings with the EMA and other agencies, as necessary.
• Review core dossier (Module 2-5) provided by Global to ensure regulatory requirements are met for the EU region.
• Author M1-3 content for new marketing authorisation applications in line with the regulatory requirements in the business region.
• Ensure submission progress concern is communicated to manager with proposals to mitigate any risks to timelines.
• Coordinate the submission of regulatory applications with Submission Management colleagues.
• Liaise with regulatory authorities to facilitate the prompt review and approval of applications.
• Follow company procedures concerning archiving of correspondence to and from regulatory agencies and recording submission related milestones in the company's regulatory database.
• Lead or support regulatory due diligence activities in relation to new business opportunities. Develop an appropriate regulatory strategy, risk assessment and probability of regulatory success (PRS) for assigned projects.
• Keep up to date with respect to changes in the EU regulatory environment and share learnings with colleagues.
• Work closely with peers within, and across, sites to align processes, systems, working practices, and quality standards.
• Contribute to the production of Regulatory Affairs SOPs, job aids and best practices as required.

Education, Skills and Experience:

• Comprehensive knowledge of the European regulatory environment
• Scientific degree
• Sound understanding of European regulatory guidelines.
• Proven experience of preparing and submitting marketing authorisation applications through the Centralised, Mutual Recognition and Decentralised Procedures.
• Working with regulatory agencies to facilitate approval of submissions.
• Proficient at managing complex regulatory projects, identifying submission risks and mitigation strategies. Commercial Awareness
• Demonstrated ability to appropriately prioritise workload taking into account the commercial value of the regulatory work being requested.
• Able to identify and communicate areas of risk within a regulatory strategy. Strong problem identification and solving skills.

To Apply:

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 call Peter Duvall on +44 203 0789 542 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.