Senior Regulatory Specialist
East Sussex, England, United Kingdom Full-time Posted 2 weeks ago
About This Job
Walker Cole International
Location: South East, England, United Kingdom
Work Mode: On-site
Industry: Pharmaceutical Manufacturing
Job Description
Our client, a leading global consumer healthcare organisation, is looking for a Senior Regulatory Affairs Specialist to join their EMEA Regulatory Affairs team (hybrid working).
This is a fantastic opportunity for an experienced regulatory professional to take ownership of a broad and varied portfolio, working across EU regulatory procedures and playing a key role in maintaining and expanding a well-established medicinal products portfolio.
What You'll Be Doing
Leading on regulatory submissions in line with EU requirements (MRP/DCP), ensuring the ongoing maintenance and compliance of existing marketing authorisationsManaging non-CMC lifecycle activities, including variations, renewals and safety updatesCollecting and evaluating regulatory, quality, preclinical and clinical data to support complianceLiaising directly with Health Authorities, proactively seeking opportunities to expedite approvalsPrioritising and managing multiple projects against agreed timelinesEnsuring all assigned products remain compliant with local regulatory and quality requirementsSupporting internal audits and inspectionsPartnering cross-functionally to manage crises and sensitive regulatory issuesDriving local process improvements within the regulatory function
What We're Looking For
A relevant Bachelor's degree or higherSignificant experience within a Regulatory Affairs , ideally within non-prescription EU procedures (MRP/DCP)Proven track record managing non-CMC lifecycle activities and safety updatesStrong attention to detail and excellent organisational skillsConfident communicator, able to simplify complex regulatory topics for varied audiencesA collaborative mindset with a strong sense of ownership and accountabilityComfortable operating in a fast-paced, matrixed, multicultural environmentFluent in English
Desirable
Experience within the consumer healthcare sectorUnderstanding of cross-functional processes within a healthcare organisation
Walker Cole International
Location: South East, England, United Kingdom
Work Mode: On-site
Industry: Pharmaceutical Manufacturing
Job Description
Our client, a leading global consumer healthcare organisation, is looking for a Senior Regulatory Affairs Specialist to join their EMEA Regulatory Affairs team (hybrid working).
This is a fantastic opportunity for an experienced regulatory professional to take ownership of a broad and varied portfolio, working across EU regulatory procedures and playing a key role in maintaining and expanding a well-established medicinal products portfolio.
What You'll Be Doing
Leading on regulatory submissions in line with EU requirements (MRP/DCP), ensuring the ongoing maintenance and compliance of existing marketing authorisationsManaging non-CMC lifecycle activities, including variations, renewals and safety updatesCollecting and evaluating regulatory, quality, preclinical and clinical data to support complianceLiaising directly with Health Authorities, proactively seeking opportunities to expedite approvalsPrioritising and managing multiple projects against agreed timelinesEnsuring all assigned products remain compliant with local regulatory and quality requirementsSupporting internal audits and inspectionsPartnering cross-functionally to manage crises and sensitive regulatory issuesDriving local process improvements within the regulatory function
What We're Looking For
A relevant Bachelor's degree or higherSignificant experience within a Regulatory Affairs , ideally within non-prescription EU procedures (MRP/DCP)Proven track record managing non-CMC lifecycle activities and safety updatesStrong attention to detail and excellent organisational skillsConfident communicator, able to simplify complex regulatory topics for varied audiencesA collaborative mindset with a strong sense of ownership and accountabilityComfortable operating in a fast-paced, matrixed, multicultural environmentFluent in English
Desirable
Experience within the consumer healthcare sectorUnderstanding of cross-functional processes within a healthcare organisation
