Senior Manager, Regulatory Affairs
hace 2 meses
Requisition Number 7883 Employment Type : Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.
Anchored in our company's scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.
Our talented team of 3,000+ professionals spans 60+ countries.
We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
What you will do Review study budgets and costing pertaining to contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs.
Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions.
Provide expert regulatory advice and contribute to regulatory project work.
Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, Medical & Scientific Affairs staff.
Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country specific requirements.
Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff.
What you will bring to the role Clearly, proven leadership and organizational management skills are essential attributes.
Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
Excellent written and verbal communication skills to clearly and concisely present information.
Relationship-building competency combined with demonstrated comfort supporting Business Development at face-to-face meetings.
Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment.
Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
Your experience A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR… Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree) and eight years' experience within clinical research (e.g.
CRA, Reg Affairs).
Minimum 7 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience.
Proficient in cross-cultural communication and proficient in both spoken and written English.
We love knowing that someone is going to have a better life because of the work we do.
#J-18808-Ljbffr
-
Senior Manager, Regulatory Affairs
hace 2 meses
Orense, España Worldwide Clinical Trials A tiempo completo.Requisition Number7883Employment Type:RegularWho we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company's scientific heritage, our...
-
Energy Efficiency Manager
hace 1 mes
Orense, España Data4 Group A tiempo completo.ABOUT THE ROLEThe resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate an excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Energy Efficiency Manager
hace 4 días
Orense, España Data4 Group A tiempo completo.ABOUT THE ROLEThe resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Energy Efficiency Manager
hace 4 días
Orense, España Data4 Group A tiempo completo.ABOUT THE ROLE The resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Energy Efficiency Manager
hace 1 mes
Orense, España Data4 Group A tiempo completoABOUT THE ROLE The resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate an excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Energy Efficiency Manager
hace 1 mes
Orense, España Data4 Group A tiempo completoABOUT THE ROLE The resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites.To ensure future datacenters growth, it is critical to demonstrate an excellent track record and very high engagement to reduce resource usage while keeping customer service quality.The...
-
Energy Efficiency Manager
hace 1 mes
Orense, España Data4 Group A tiempo completoABOUT THE ROLE The resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites.To ensure future datacenters growth, it is critical to demonstrate an excellent track record and very high engagement to reduce resource usage while keeping customer service quality.The...
-
Energy Efficiency Manager
hace 4 días
Orense, España Data4 Group A tiempo completoABOUT THE ROLEThe resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Energy Efficiency Manager
hace 4 días
Orense, España Data4 Group A tiempo completoABOUT THE ROLE The resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites.To ensure future datacenters growth, it is critical to demonstrate excellent track record and very high engagement to reduce resource usage while keeping customer service quality.The...
-
Energy Efficiency Manager
hace 1 mes
Orense, España Data4 Group A tiempo completoABOUT THE ROLEThe resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate an excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Energy Efficiency Manager
hace 3 días
Orense, España Data4 Group A tiempo completoABOUT THE ROLEThe resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Energy Efficiency Manager
hace 4 días
Orense, España Data4 Group A tiempo completoABOUT THE ROLEThe resource efficiency manager is a critical role at Data4 to ensure leading practices in terms of environmental impact and sustainability across all sites. To ensure future datacenters growth, it is critical to demonstrate excellent track record and very high engagement to reduce resource usage while keeping customer service quality. The...
-
Senior Manager, Global Procurement
hace 3 semanas
Orense, España Pharmanovia A tiempo completoBasildon and London or Spain: hybrid role (3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed, and innovative pharmaceutical senior supply chain professional with direct/indirect category experience in global procurement then we want to hear from you! Join us to help improve peoples’ lives and make...
-
Senior Manager, Global Procurement
hace 2 meses
Orense, España Pharmanovia A tiempo completo.Basildon and London or Spain: hybrid role (3 days office, 2 days home per week)Salary: Competitive + Benefits + BonusIf you are an agile, committed, and innovative pharmaceutical senior supply chain professional with direct/indirect category experience in global procurement then we want to hear from you!Join us to help improve peoples' lives and make...
-
Senior Manager, Global Procurement
hace 1 mes
Orense, España Pharmanovia A tiempo completoBasildon and London or Spain: hybrid role (3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed, and innovative pharmaceutical senior supply chain professional with direct/indirect category experience in global procurement then we want to hear from you!Join us to help improve peoples' lives and make...
-
Senior Manager, Global Procurement
hace 2 meses
Orense, España Pharmanovia A tiempo completoBasildon and London or Spain: hybrid role (3 days office, 2 days home per week) Salary: Competitive + Benefits + Bonus If you are an agile, committed, and innovative pharmaceutical senior supply chain professional with direct/indirect category experience in global procurement then we want to hear from you!Join us to help improve peoples' lives and make...
-
Senior Manager, Global Procurement
hace 2 meses
Orense, España Pharmanovia A tiempo completoBasildon and London or Spain: hybrid role (3 days office, 2 days home per week)Salary: Competitive + Benefits + BonusIf you are an agile, committed, and innovative pharmaceutical senior supply chain professional with direct/indirect category experience in global procurement then we want to hear from you!Join us to help improve peoples' lives and make...
-
Orense, España Jbandrews A tiempo completo.Job Reference: 10063TV - BLProject Manager Warehousing – Southern EuropeContinent: Europe Location: Spain, Italy or Cyprus Market: logistics Industry: Contract Logistics Salary: In line with market expectationsThe Client:JBAndrews is working with a global Logistics provider operating globally across multiple industries, with a focus on Retail, Fashion,...
-
Orense, España Jbandrews A tiempo completo.Job Reference: 10063TV - BLProject Manager Warehousing – Southern EuropeContinent: EuropeLocation: Spain, Italy or CyprusMarket: logisticsIndustry: Contract LogisticsSalary: In line with market expectationsThe Client:JBAndrews is working with a global Logistics provider operating globally across multiple industries, with a focus on Retail, Fashion, FMCG,...
-
Orense, España Jbandrews A tiempo completoJob Reference: 10063TV - BL Project Manager Warehousing – Southern Europe Continent: Europe Location: Spain, Italy or Cyprus Market: logistics Industry: Contract Logistics Salary: In line with market expectations The Client: JBAndrews is working with a global Logistics provider operating globally across multiple industries, with a focus on Retail, Fashion,...
