My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Consultant to be based in their offices in Berkshire on an initial 12 month contract - post COVID.
- Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA
- Acts as the Regulatory responsible for providing regulatory information on assigned products and to develop strategies, objectives, tactics and timelines for those products throughout their lifecycle
- Works with the Area Regulatory team to advocate for the affiliate's strategy objectives and timelines
- Serves as Health Authority liaison and interfaces with Health Authority for meetings, teleconference, etc. to obtain optimal outcomes for patients and internal portfolio
- Ensures compliance within the regulatory department and collaborates with internal stakeholders, as appropriate, to ensure compliance with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company
- Quality control check members of staff's work, correct where necessary and provide feedback.
- Provide continuous feedback on UK national regulatory activities
- Ensures submission and content of new Marketing Authorisations, variations and other regulatory submissions, including label, artwork and local prescribing information are made in accordance with appropriate timings and requirements and maintain an appropriate tracking of the process as applicable, working with the Regulatory Processes Co-coordinator as applicable
- Ensures appropriate and timely communication of regulatory and safety information within the regulatory department, relevant internal stakeholders, as well as to the Regulatory authorities, as required by local regulation, company policies and procedures
- Keeps up-to-date with all appropriate Regulatory issues and operate as a 'problem-solver', to provide effective resolution of regulatory issues occurring within the UK, with an appreciation of business needs and priorities and will escalate to the Manager, Regulatory Affairs as necessary.
- Builds business relationships with key internal stakeholders, including Area Regulatory Affairs, Medical Affairs, Commercial and QA, as required to enable good cross-functional working.
- Stays abreast of all Regulatory intelligence updates and is proactive regarding implementation of necessary legislation/regulation changes.
- Life Sciences Degree or equivalent experience
- Varied experience within Regulatory Affairs, including commercial affiliate awareness and national and mutual recognition product lifecycle management
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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