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Regulatory Affairs Associate
1 week ago
Proclinical Staffing Hampshire, United KingdomThe candidate must have UK level submission experience. · The purpose of the Regulatory Affairs Associate/Senior Associate role is to manage the operational and technical aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese marketing affiliate, ...
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Regulatory Affairs Associate
1 week ago
Proclinical Staffing Hampshire, United KingdomJob Description · The candidate must have UK level submission experience. · The purpose of the Regulatory Affairs Associate/Senior Associate role is to manage the operational and technical aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese ma ...
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Regulatory Affairs Associate
1 week ago
Proclinical Staffing Hampshire, United KingdomThe candidate must have UK level submission experience.The purpose of the Regulatory Affairs Associate/Senior Associate role is to manage the operational and technical aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese marketing affiliate, in ...
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Regulatory Affairs Associate
1 week ago
Cpl Hampshire, United Kingdom FreelanceJob Title: Regulatory Affairs Associate (UK, Ireland & Malta) · Location: Hampshire, UK · Employment Type: 12 Month Contract (inside IR35) · Rate: £14.68 and £19.57 per hour PAYE only · The purpose of the Regulatory Affairs Associate/Senior Associate role is to manage the operat ...
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Careers In Group Hampshire, United KingdomRisk, compliance, FCA, Insurance, Hampshire, Basingstoke, Financial crime, · - Compliance monitoring · **Risk & Compliance Outsourcer Manager - 1 Year FTC - Hampshire - Hybrid Working · Your new company** · A financial services organisation based in Hampshire are looking to recru ...
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Risk & Compliance Manager - Insurance - Ftc
1 week ago
MERJE Ltd Hampshire, United KingdomFocused in the Life industry, this firm has been established for over 100 years and is going through an integration project, leading to require extra specialist compliance expertise for the management of key deliverables during this period of transition. · This role supports the ...
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Corporate Solicitor Hampshire 1 Year Pqe
1 week ago
The Legists Hampshire, United Kingdom** · Corporate Solicitor - Hampshire - 2 Years + · Our Top 100 client now seeks to expand its Corporate presence on the Hampshire coast. · The Corporate team acts across all sectors on a variety of corporate transactions. They advise UK and international clients on all aspects fr ...
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Compliance Manager
2 days ago
H2O Recruitment Services Ltd Hampshire, United KingdomCompliance Manager (South) Cemap · Fulltime, Monday to Friday (Home Based) · My client are looking to expand their amazing Compliance team to deliver their innovative, tech driven T&C Scheme. · Reporting to one of their Regional Field Operations Managers, The CM's are responsible ...
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Paraplanner
1 day ago
Radley Recruitment Hampshire, United Kingdom**Paraplanner, (Diploma 4 Qualified or Part-Qualified) - Salary up to £45,000DOE + £4,000 initial bonus + Excellent Benefits** · **Based: Home Based or office** · We are searching for **experienced** and **professional Holistic and DB Pensions Paraplanners** to join our market le ...
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Maintenance Surveyor
1 week ago
Sovereign Housing Hampshire, United KingdomAs a leading 60,000+ home housing Association, **Sovereign** are committed to providing quality, affordable homes, and services within sustainable, successful communities. We're led by our values and driven by a strong social purpose, placing our customers at the heart of everyth ...
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Technical Surveyor
5 days ago
Sovereign Housing Hampshire, United KingdomAs a leading 60,000+ home housing Association, **Sovereign** are committed to providing quality, affordable homes, and services within sustainable, successful communities. We're led by our values and driven by a strong social purpose, placing our customers at the heart of everyth ...
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Regulatory Affairs Role
1 week ago
Planet Pharma Hampshire, United KingdomRole: Regulatory Affairs Role · Type: Contract · Location: Hampshire · Duration: 12 Month · We are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ensure the success of ne ...
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Regulatory Affairs Role
1 week ago
Planet Pharma Hampshire, United KingdomJob Description · Role: Regulatory Affairs Role · Type: Contract · Location: Hampshire · Duration: 12 Month · We are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ensure ...
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Regulatory Affairs contractor
1 week ago
Planet Pharma Hampshire, United Kingdom FreelanceRole: Regulatory Affairs Role Type: Contract · We are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ensure the success of new product registrations for an initial 12-mo ...
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Regulatory Affairs Role
1 week ago
Planet Pharma Hampshire, United KingdomRole: Regulatory Affairs Role · Type: Contract · Location: Hampshire · Duration: 12 Month · We are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ensure the success o ...
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Electronic Design Engineer
1 day ago
XB Consultants Hampshire, United KingdomJob Description Job Title: Electronic Design Engineer - Mixed signal - Senior level · Position Overview: · We are seeking a talented Electronic Design Engineer - Mixed Signal Electronics to join one of our successful clients a renowned global R&D/ high-tech organization curren ...
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Regulatory Affairs contractor
1 week ago
Planet Pharma Hampshire, United Kingdom FreelanceJob Description Role: Regulatory Affairs Role · Type: Contract · We are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ensure the success of new product registrations f ...
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Electronic Design Engineer
6 days ago
XB Consultants Hampshire, United KingdomJob Title: Electronic Design Engineer - Mixed signal - Senior level · Position Overview: · We are seeking a talented Electronic Design Engineer - Mixed Signal Electronics to join one of our successful clients a renowned global R&D/ high-tech organization currently expanding their ...
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Regulatory Affairs Role
1 week ago
Planet Pharma Hampshire, United KingdomJob Description Role: Regulatory Affairs Role · Type: Contract · Location: Hampshire · Duration: 12 Month · We are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ens ...
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Regulatory Affairs Role
1 week ago
Planet Pharma Hampshire, United KingdomRole: Regulatory Affairs RoleType: ContractLocation: HampshireDuration: 12 MonthWe are currently partnered with a global Pharmaceutical company who are now looking for a regulatory affairs associate to execute the Regulatory Plan/objectives to ensure the success of new product re ...
Quality & Regulatory Associate - Hampshire, United Kingdom - Proclinical Staffing
Description
The purpose of the Regulatory Affairs Associate/Senior Associate role is to manage the operational and technical aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese marketing affiliate, including:Execute the Regulatory Plan/objectives to ensure the success of new product registrations, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements
Foster an environment of operational excellence and collaborate with cross functional teams to successfully achieve affiliate regulatory objectives
Facilitate and cultivate relationships with the local regulatory agencies and trade associations
Regulatory Plan Execution
Implement the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.
Ensure submission and approval of high quality regulatory applications within planned timeframes. Maintain or support maintenance of clear metrics for regulatory deliverables.
Voicing affiliate perspective and needs to global and regional regulatory contacts
Ensuring timely responses to requests from support groups and/or regulatory authorities
Maintain regulatory tools in alignment with defined compliance metrics
Support affiliate launch teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plans
Represent the regulatory affairs function as appropriate in brand teams and New Product Planning discussions
Maintain awareness of current regulations and anticipate implications and opportunities of changes in the regulatory environment. Facilitate interactions with regulatory bodies on a regular basis
Support the implementation of any additional risk minimization measures at the affiliate and ensure appropriate metrics are generated
Perform the function of Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or regulatory authority timeframes
Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labelling
Regulatory Compliance
Ensure that internal regulatory IT tools and trackers are up to date and accurate
Ensure that all products comply with local regulations and quality system requirements whichever is more stringent
Ensure that the regulatory archive is complete and up to date and ensure that all current licenses and labels are readily available
Support internal audits / assessments / self-inspections / external inspections in collaboration with Medicines Quality Organisation and local Ethics and Compliance
Raise awareness to leadership and relevant functions on compliance issues and initiatives and provide technical support to other affiliate functions
Support implementation of local quality system in line with the global quality system and local regulations
Ensure alignment and implementation of internal regulatory initiatives
Actively participate in affiliate cross-functional teams and provide regulatory input and knowledge
Support implementation of launch readiness initiatives
Build and maintain relationships with key regulatory officials and trade associations
Provide affiliate training and education on regulatory matters and provide regulatory input to affiliate strategic initiatives
Personal and Professional Development
Knowledge and understanding of local regulations and local, regional and global regulatory procedures
Bachelor's degree or equivalent in a relevant scientific subject
At least one year industry related experience in regulatory affairs and experience of dealing with external regulatory agencies, the health care system and marketing needs
Demonstrated good computer/IT skills
Good knowledge of written and spoken English
Project management skills
Strong planning and priority setting
Good capability to establish positive networking both internally and externally (e.g. trade associations)
Knowledge of Quality systems
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
