ProClinical is advertising an opportunity for a Regulatory Consultant position with one of the most prestigious organisations in the pharmaceutical industry. This company specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas, including oncology, cardiology, and immunology. This company is seeking for a Regulatory Consultant to work on a contract basis in their office in London.
The Regulatory Consultant will obtain, manage, and maintain Marketing Authorisations and Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements.
- Contributing to Cross-functional Teams and building Regulatory Expertise.
- Utilising regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
- Representing Regulatory Affairs on product-based teams.
- Providing regulatory input to commercial, strategic, and operating planning processes.
- Attending relevant product team meetings with cross-divisional colleagues to provide technical guidance and support for teams as necessary.
- Ensuring teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation will cause for commercial activities.
- Keeping cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
- Working with WSR regional strategists to provide country input into Global and European Regulatory Strategies as required.
- Providing Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
- Partnering with above-country operational hubs to prepare and collate information needed for contribution to departmental and ad hoc reports.
- Managing and Submitting Marketing Authorisation Applications.
- Partnering with above-country operational hubs and WSR strategists to review, coordinate, and where required, creating necessary technical data to support country submissions.
- Reviewing and approving proposed regulated documents, and associated artwork in line with regulations.
- Managing and Submitting MA Variation Applications.
- Preparing agreed Module 1 and 2 documents in partnership with above-country operational hubs, WSR strategists, and with local medical functions.
- Working with WSR strategists and, above country operational hubs to supply country documentation to support Centralised product variations, and to ensure effective coordination of Mutual Recognition and Decentralised variations.
- Leading MRP submission reviews and planning where country is RMS, in conjunction with WSR strategist.
- In partnership with above country operational hubs and WSR strategists, responding to Regulatory Authority queries and inputting aggregate safety reports.
- Providing calendar data to above country operational hubs, as needed.
- Influencing Regulatory Authorities; proactively taking opportunities to develop working relationships with Regulatory Authorities and trade associations.
- Developing and enacting appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
- Utilising local knowledge of Regulatory Authorities expectations, ways of working, etc, to appropriately direct company strategy.
- Working out with authorities if company position differs from authority position in order to obtain a better outcome for the business/patients.
- Managing Clinical Trial Approvals; liaising with clinical research project managers to seek to understand the clinical research program.
- Preparing agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA, including repose to Regulatory Authority queries.
- Obtaining Authority Approvals for Supply of Unlicensed Medicines.
- Obtaining necessary approvals to import and supply unlicensed company medicines to address unmet patient needs.
- Preparing and submitting applications to discontinue products to Regulatory Authorities and notify intent to discontinue a medicine to the Ministry of Health.
- Liaising with product team/commercial/medical functions and advising on regulatory action required for discontinuation of a product in the country marketplace.
- Contributing to Good Regulatory Practice (appropriate for all tasks). Adhering to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained.
Skills and Requirements:
- At least a bachelor's in a life science or chemistry field (honours level), or equivalent. Masters' Degree, Post Graduate Diploma, or PhD preferred.
- Relevant Professional Qualifications, such as an MSc in Regulatory Affairs.
- Demonstrable experience and proven track record in Regulatory Affairs (Human Medicinal Products).
- A membership of the Organisation for Professionals in Regulatory Affairs (TOPRA) preferred.
- Excellent written and verbal communication 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 Numhom Sudsok on +44 203 871 8093 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.
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