Regulatory Affairs Manager Cmc
hace 2 semanas
Oxford Global Resources is seeking a Global CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma company to support headquartered in Barcelona through our consulting services division.Key Responsibilities:Provide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC technical functions on CMC / Quality regulations and guidelines according to the Agencies expectations for successful approvals.Provide significant contribution or leading efforts for the authoring of CMC documents for the submission to Health Authorities (HA), including MAA preparation, post-approval variations and responses to HA questions, as well as IMPDs for products under development.Coordinate any CMC regulatory activity required to expand the company portfolio in different territories (e.g.
LATAM, APAC, EMA), in close collaboration with internal stakeholders (International Pharma Sales, affiliates, CMO management, etc.)
as well as partners and potential vendors.Collaborate in the assessment of Business Development opportunities in relation to CMC topics.Ensure compliance with global regulatory requirements and contribute to the development of internal global standard operating procedures and guidance documents as needed.Establish good collaboration and interactions across various functions and teams, such as manufacturing sites (CMOs), Quality Assurance, supply chain, etc.Ensure to be up to date with CMC regulatory intelligence relevant to the company portfolio and pipeline.Requirements, Skills, and Qualifications:Bachelor's degree in Life Sciences or a related field.Fluency in English for business communication.Minimum 5 years in Regulatory CMC field for pharmaceutical products, ideally at a global level.Strong scientific and technical CMC knowledge, along with strategic regulatory mindset.
Good knowledge of international CMC regulatory legislation.Proven track record of effective collaboration with CMOs, partners and Health Authorities in gaining regulatory approvals and managing life cycle of approved products in different geographical areas.Demonstrable submission history experience for EU and other international territories.Knowledge of regulatory frameworks for medical devices and food supplements desirable.
#J-18808-Ljbffr
-
Derivatives Sales Manager
hace 7 días
Castelló de la Plana, Castellón, España Cmc Markets A tiempo completoAs a Derivatives Sales Manager at CMC Markets, you will play a critical role in driving business growth and developing strategic partnerships that expand our customer base and increase revenue.About the RoleYou will be responsible for identifying and pursuing new business opportunities, building and maintaining strong relationships with existing clients, and...
-
Account Executive
hace 1 semana
Castelló de la Plana, Castellón, España Cmc Markets A tiempo completoSince launching in 1989, CMC Markets has become one of the world's leading online CFD and financial spread betting providers, with nearly 70 million trades executed annually across Europe, Asia Pacific and North America.CMC Markets' success is founded on its ability to deliver a wide range of trading products to customers, from single equities to indices,...
-
Regulatory Project Manager
hace 12 horas
Castelló de la Plana, Castellón, España beBee Careers A tiempo completoSalary:">The salary range for this position is competitive and based on qualifications and experience.Job Summary:">We are seeking a Senior Promotional Expert to lead our promotional materials and compliance efforts in Spain. The ideal candidate will have a deep understanding of Spanish regulations and a proven track record of developing effective compliance...
-
Financial Trader Specialist
hace 7 días
Castelló de la Plana, Castellón, España Cmc Markets A tiempo completoDrive business growth and deliver exceptional client experiences as a Financial Trader Specialist at CMC Markets.Job DescriptionServe as the primary point of contact for clients, providing proactive relationship management, business development, and execution services to drive revenue growth and maximize client retention.Maintain a deep understanding of...
-
Market Growth Executive
hace 7 días
Castelló de la Plana, Castellón, España Cmc Markets A tiempo completoAs a Market Growth Executive at CMC Markets, you will be responsible for driving business growth and expansion through strategic partnerships, innovative sales approaches, and exceptional client experiences.Your Key ResponsibilitiesIdentify and pursue new business opportunities, building relationships with key decision-makers and influencers in the...
-
Client Portfolio Director
hace 7 días
Castelló de la Plana, Castellón, España Cmc Markets A tiempo completoWe are seeking an experienced Client Portfolio Director to join our team at CMC Markets. As a key member of our sales leadership team, you will be responsible for driving business growth and delivering exceptional client experiences.About the RoleYou will be responsible for managing a portfolio of high-value clients, developing and executing targeted...
-
Castelló de la Plana, Castellón, España DaoPay A tiempo completoDigital payment solutions provider DaoPay seeks a Regulatory Affairs Specialist to join its Compliance & Risk Team. The successful candidate will execute KYC and AML due diligence for new and existing merchants, perform transaction monitoring, and contribute to maintaining internal records and compliance documentation.Job DescriptionThe Compliance / AML...
-
Principle Regulatory Systems Manager
hace 2 semanas
Castelló de la Plana, Castellón, España Dna Life Sciences A tiempo completoPrinciple Regulatory Systems Manager (xEVMPD and IDMP, RIM Systems implementation) - Pharmaceutical And BiotechDNA life Sciences is working with a specialized consultancy focused on delivering innovative solutions to drive digital transformation within the Life Sciences and Pharmaceutical sectors.They support organizations in enhancing their regulatory...
-
Senior Promotional Expert
hace 12 horas
Castelló de la Plana, Castellón, España beBee Careers A tiempo completoSalary:">The compensation package for this role includes a competitive salary and comprehensive benefits.About the Job:">This is a unique opportunity to join our team as a Regulatory Project Manager and play a key role in ensuring the success of our promotional materials and compliance initiatives in Spain.Main Responsibilities:Develop and implement...
-
Technical Innovation Leader Position
hace 2 semanas
Castelló de la Plana, Castellón, España Jordan Martorell S.L. A tiempo completo**Job Overview**We are seeking a skilled Technical Transformation Project Manager to join our Technical Transformation team. The successful candidate will be responsible for identifying innovative technological solutions that drive the development and launch of competitive products in terms of quality, cost, and sensory performance. Key responsibilities...
-
Promotional Materials Coordinator
hace 12 horas
Castelló de la Plana, Castellón, España beBee Careers A tiempo completoSalary:">The successful candidate can expect a competitive salary and benefits package.Job Description:">This is an exciting opportunity for a skilled Regulatory Project Manager to join our team. As a key member of our compliance department, you will be responsible for ensuring that all promotional materials and activities comply with relevant laws and...
-
Financial Regulatory Manager
hace 2 semanas
Castelló de la Plana, Castellón, España Bit2Me A tiempo completo¿Te apasiona liderar la estrategia financiera desde una perspectiva regulatoria? Estamos buscando un/a Financial Regulatory Manager para liderar el área de finanzas regulatorias, asegurando que nuestra compañía cumpla con las normativas más exigentes mientras optimizamos procesos y garantizamos resultados de alto impacto. Si te motivan los retos del...
-
Financial Regulatory Manager
hace 3 días
Castelló de la Plana, Castellón, España Bit2Me A tiempo completo¿Te apasiona liderar la estrategia financiera desde una perspectiva regulatoria?Estamos buscando un/a Financial Regulatory Manager para liderar el área de finanzas regulatorias, asegurando que nuestra compañía cumpla con las normativas más exigentes mientras optimizamos procesos y garantizamos resultados de alto impacto. Si te motivan los retos del...
-
Regulatory Affairs Specialist
hace 6 días
Castelló de la Plana, Castellón, España HIPRA A tiempo completoCuentas con formación en Relaciones Laborales y tienes experiencia en gestión de nóminas? ¿Has trabajado con Contrat@, Sistema Red y / o Siltra? Si buscas un nuevo reto en un entorno dinámico dentro de una compañía líder en el sector turístico, te estamos esperandoComo Payroll Specialist formarás parte del equipo corporativo de RRHH y tu principal...
-
Technical Transformation Project Manager
hace 4 semanas
Castelló de la Plana, Castellón, España Jordan Martorell S.L. A tiempo completoAt GBfoods we offer culinary solutions in several countries of Europe and Africa with prestigious leading local brands, including Jumbo, Gallina Blanca, Erasco, Gino, Liebig, Star, Bama, D&L, Grand'Italia and Blå Band, among others.Our Purpose "Celebrating local flavours" is to empower and take care of each of the local communities we belong to and to bring...
-
Product Manager
hace 9 horas
Castelló de la Plana, Castellón, España beBee Careers A tiempo completoJob SummaryWe are seeking a highly motivated and experienced Product Manager to lead our product development efforts. As a key member of our team, you will be responsible for defining and implementing strategies to meet market requirements for our product menu."> Develop and execute marketing support programs for specific products or product lines.Coordinate...
-
Castelló de la Plana, Castellón, España DaoPay A tiempo completoDaoPay, a leading fintech company, seeks a Risk and Compliance Manager to lead its Compliance & Risk Team. This role requires a Compliance Officer with expertise in AML/CFT principles, onboarding requirements, and risk assessment, as well as familiarity with the European legal framework, ideally including the Austrian Fm-GwG.Your Key ResponsibilitiesDevelop...
-
Manufacturing Operations Manager
hace 3 días
Castelló de la Plana, Castellón, España Royal Caribbean Group A tiempo completoAbout the RoleThe Royal Caribbean Group is seeking a skilled Manufacturing Operations Manager to oversee daily operations in a cleanroom environment. As part of our team, you will ensure compliance with cGMP regulations and lead a team of operators in aseptic processing, filling, and finishing of pharmaceutical or biologic products.Key...
-
Global Study Start-Up Manager
hace 12 horas
Castelló de la Plana, Castellón, España beBee Careers A tiempo completoJob OverviewThe Global Study Start-Up Manager is responsible for defining, developing, and delivering the global study start-up project strategy. This includes partnering with country/site feasibility specialists to incorporate up-to-date intelligence for the planned countries and sites into the overall start-up strategy and site activation plan. The manager...
-
Security Solutions Business Growth Manager
hace 3 días
Castelló de la Plana, Castellón, España SICPA A tiempo completoJob DescriptionWe are seeking a highly skilled and experienced individual to lead our sales efforts in the document security industry.This role involves identifying new business opportunities, managing relationships with key stakeholders, and securing high-value contracts for secure document solutions.The position reports to the local General Manager, with a...