- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
- Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
- Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
- Works within a project team, and where necessary, leads project for the region or globally
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
- Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
- Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
- Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
- Provides ICH GCP guidance, advice and training to internal and external clients
- Serve as representative of Global Regulatory Affairs at business development meetings
- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
- Computer literacy (MS Office/ Office 365)
- Fluent in English
- Graduate, postgraduate
- Possesses basic understanding of financial management
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
- Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
- Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
- Availability for domestic and international travel including overnight stays
- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
- Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
- Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
- Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
- Motivates other members of the project team to meet timelines and project goals
- Flexible attitude with respect to work assignments, and new learning
- Resolves project related problems and prioritize workload to meet deadlines with little support from management
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
- Collects data of consistently high standard
- Communicates effectively in the English language both verbally and in written form
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
-
Regulatory Reporting Manager
hace 1 semana
Santander Boadilla del Monte, EspañaREGULATORY REPORTING MANAGER (BANCA MAYORISTA) · Country: Spain · **WHAT YOU WILL BE DOING** · **Santander Back-Offices Globales Mayoristas (SBGM) **es una sociedad anónima, cuyo capital social es 100% propiedad del Banco Santander y se encuentra englobada dentro de la División d ...
-
Regulatory Manager
hace 3 días
Precision Medicine Group Madrid, EspañaPosition Summary: · The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well orga ...
-
Regulatory Manager
hace 1 semana
Ebury Madrid, EspañaEbury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. · **Regulatory Reporting Man ...
-
Regulatory Manager
hace 2 días
Ebury Madrid, EspañaEbury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. · **Regulatory Reporting Man ...
-
Regulatory Manager
hace 5 días
Ebury Madrid, España-Ebury · Madrid, Spain · Posted 20 hours ago Hybrid Permanent Competitive · - Ebury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency acco ...
-
Regulatory Reporting Manager
hace 2 días
Ebury Madrid, EspañaEbury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. · **Regulatory Reporting Man ...
-
Regulatory Reporting Manager
hace 2 días
Ebury Madrid, EspañaEbury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. · As a Regulatory Reporting ...
-
Regulatory Affairs Manager
hace 1 semana
Worldwide Clinical Trials Madrid, España**Requisition Number** · **6658** · **Employment Type***: · **Regular** · **Who we are** · We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is b ...
-
Regulatory Affairs Manager
hace 2 días
PrimeVigilance Madrid, EspañaCompany Description · We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all coveri ...
-
Financial Regulatory Reporting Manager
hace 1 semana
Ebury Madrid, EspañaEbury is a hyper-growth FinTech firm, named in 2021 as one of the top FinTechs to work for by Glassdoor and AltFi. We offer a range of products including FX risk management, trade finance, currency accounts, international payments and API integration. · As a Financial Regulatory ...
-
Public Affairs and Regulatory Manager
hace 10 horas
ENI Madrid, EspañaOPEN DATE-CLOSING DATE: 23/02/2024-08/04/2024 · European Union-Spain-MADRID-ES-MADRID GLORIETA DE QUEVEDO · PROFESSIONAL FAMILY: LEGAL AFFAIRS · Home National | Expert | Residential · **IRC PUBLIC AFFAIRS AND REGULATORY MANAGER** · At **Eni**, we are looking for a **Public Affair ...
-
Project Manager for Regulatory Division
hace 3 días
Dekra EspañaSince its foundation in 1925, the DEKRA promise has been to ensure the safety of human interaction with technology and the environment. DEKRA achieved revenues of around €3.1 billion in 2019. The company currently employs around 47,000 people in more than 60 countries on all five ...
-
Public Affairs and Regulatory Manager Spain
hace 2 días
Statkraft Madrid, EspañaPublic Affairs and Regulatory Manager Spain · - Full-time · **Company Description**: · Statkraft has been making clean energy possible for over a century. Today, we are Europe's largest renewable energy producer and a global energy market operator. We are a vibrant, diverse and s ...
-
Regulatory Affairs Manager Emea/apac
hace 4 días
Blu Selection Madrid, EspañaOur client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions. · **Your Responsibilities and Impact as Regulatory Affairs Manager will be**: · - Supervising Regulatory Aff ...
-
Medical Writing Manager(Regulatory Experience
hace 1 semana
Syneos Health Clinical Madrid, España**Description** · **Manager, Medical Writing** · Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value ...
-
Regulatory Manager
hace 1 semana
Precision For Medicine Madrid, EspañaPrecision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland. · Position Summary: · The Regulatory Manager (RM) provides regulatory strategy and devel ...
-
Associate Director, Commercial Quality Assurance
hace 2 días
Lilly Alcobendas, EspañaAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...
-
Medical Scientific Liaison Gastroenterology
hace 3 días
Eli Lilly Alcobendas, EspañaAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, imp ...
-
Clinical Research Lead
hace 1 semana
Lilly Alcobendas, EspañaAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve th ...
-
Finance Business Partner Global E2e Supply Chain
hace 1 semana
Straumann Group Alcobendas, España**About Straumann Group**: · Headquartered in Basel, Switzerland, the Straumann Group stands at the pinnacle of dental innovation, with a reach spanning more than 100 countries worldwide. We pride ourselves on our expansive network of distribution subsidiaries and partners, showc ...
Regulatory Manager - Alcobendas, España - Precision Medicine Group
Descripción
Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland.
Position Summary:
The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.
Essential functions of the job include but are not limited to:
Qualifications:
Minimum Required:
Preferred:
Other Required:
Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
Competencies
#LI-NC1 #LI-Remote