Regulatory Manager

hace 2 semanas

Madrid, España INSUD PHARMA, S.L.U. A tiempo completo

Overview:
**General Responsibility**

The Manager, Regulatory Affairs CMC is responsible for defining and implementing global CMC strategies including regulatory relevant technical guidance to development teams and ensures adequacy of CMC documentation for global regulatory submissions. The position supports and promotes all regulatory CMC tasks throughout the product lifecycle, in collaboration with internal and external stakeholders.

**Responsibilities**:
**Specific Responsibilities**
- Responsible for defining and implementing global regulatory CMC strategies, in-line with business objectives and in cooperation with key internal and external stakeholders
- Responsible for leading the preparation/ review and approval of regulatory submissions such as INDs, CTAs, IMPDs, NDAs, BLAs, MAAs and post-approval variations, annual reports, renewals and responses to health authority questions (deficiency letters)
- Accountable for the writing of regulatory CMC sections (e.g. Module 2 and Module 3) from product development and quality source documents with following key activities:

- Lead compilation of regulatory submission packages in close collaboration with relevant stakeholders and applicable internal procedures
- Ensuring that regulatory submission packages are scientifically adequate and include appropriate level of detail
- Ensuring compliance with all applicable National and International regulations
- Defining and implementing regulatory consultation strategy (e.g. Scientific Advice, Pre-submission meetings and Health Authority engagement) including coordination of briefing package compilation if required
- Provide strategic and technical guidance on regulatory CMC topics to product development teams and commercial manufacturing sites (e.g. study protocols, study reports and technical plans)
- Ensure that regulatory risks identified during product development and\or post-approval are mitigated with the appropriate action plan(s) and incorporated into program management planning
- Responsible for the regulatory evaluation of CMC change controls and maintaining product compliance throughout the product lifecycle
- Provide regulatory CMC guidance in due diligence / commercial licensing activities
- Manage external consultants and third-party vendors/providers in the execution and performance of regulatory activitiesResponsible for the preparation and maintenance of department SOPs, KPI reporting and facilitate presentations to the mAbxience Executive Committee (MEC) on regulatory CMC strategy

Qualifications:
**equirements and personal skills**

**Education**: Degree in Life/Health Sciences (e.g. Chemistry, Biology, Biochemistry, Pharmacy), or equivalent. Advanced degree in Science preferred

**Languages**: Fluent English required (oral and written); knowledge of Spanish and other languages will be an asset

**Experience (years/area)**:

- Minimum of 5 to 7 years experience in the pharmaceutical industry, including at least 3 years experience working within a Regulatory Affairs CMC function in biopharmaceuticals and/ or biosimilars.
- Broad knowledge of global and national regulations, guidances, and polices in pharmaceutical and biologic drug development including ICH, FDA, and EMA.
- Experience in scientific writing, review and editing of CMC regulatory documents (INDs, CTAs, IMPDs, NDAs, BLAs, MAAs), including post-approval variations, annual reports, renewals and responses to health authority questions
- Experience and knowledge of e-CTD requirements for submission to major authorities such as FDA and EMA

  • Regulatory Manager

    hace 2 semanas

    Madrid, España Precision For Medicine A tiempo completo

    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,...

  • Regulatory Manager

    hace 4 semanas

    Madrid, España Ebury A tiempo completo

    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 accounts, international payments and API integration. **Regulatory Reporting Manager - 2LoD** Madrid (Office based) As a Regulatory Reporting Manager - 2LoD...

  • Regulatory Manager

    hace 4 días

    Madrid, España Ebury A tiempo completo

    -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 accounts, international payments and API integration.**Regulatory Reporting Manager -...

  • Preclinical And Regulatory Project Manager

    hace 2 semanas

    Madrid, España Josep Tabernero MD, PhD A tiempo completo

    Preclinical and Regulatory Project ManagerPreclinical and Regulatory Project Manager We are seeking a motvated Project Manager in Preclinical Development and Regulatory Afairs to join our interdisciplinary team to develop new agents designed to modulate tumor dormancy to fght cancer progression. The candidate will partcipate in a highly translatonal project...

  • Preclinical And Regulatory Project Manager

    hace 2 semanas

    Madrid, España Josep Tabernero MD, PhD A tiempo completo

    Preclinical and Regulatory Project ManagerPreclinical and Regulatory Project Manager We are seeking a motvated Project Manager in Preclinical Development and Regulatory Afairs to join our interdisciplinary team to develop new agents designed to modulate tumor dormancy to fght cancer progression. The candidate will partcipate in a highly translatonal project...

  • Regulatory Reporting Manager

    hace 4 semanas

    Madrid, España Ebury A tiempo completo

    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 accounts, international payments and API integration. **Regulatory Reporting Manager - 2LoD** Madrid (Office based) As a Regulatory Reporting Manager - 2LoD...

  • Regulatory Affairs Manager Emea/apac

    hace 4 semanas

    Madrid, España Blu Selection A tiempo completo

    Our 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 Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and...

  • Preclinical And Regulatory Project Manager

    hace 2 semanas

    Madrid, España Josep Tabernero MD, PhD A tiempo completo

    Preclinical and Regulatory Project ManagerPreclinical and Regulatory Project ManagerWe are seeking a motvated Project Manager in Preclinical Development and Regulatory Afairs to join our interdisciplinary team to develop new agents designed to modulate tumor dormancy to fght cancer progression. The candidate will partcipate in a highly translatonal project...

  • Regulatory Reporting Manager

    hace 4 semanas

    Madrid, España Ebury A tiempo completo

    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 accounts, international payments and API integration. As a Regulatory Reporting Manager, you will work in the Finance department of Ebury which sits within the...

  • Regulatory Manager

    hace 3 semanas

    Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various...

  • Financial Regulatory Reporting Manager

    hace 6 días

    Madrid, España Ebury A tiempo completo

    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 accounts, international payments and API integration. As a Financial Regulatory Reporting Manager, you will work in the Finance department of Ebury which sits...

  • Public Affairs and Regulatory Manager Spain

    hace 4 semanas

    Madrid, España Statkraft A tiempo completo

    Public 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 strongly connected community of over 4800 people, working across 19 countries within...

  • Regulatory Affairs Manager

    hace 4 semanas

    Madrid, España PrimeVigilance A tiempo completo

    Company 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 covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

  • Regulatory Manager, Clinical Trials Regulatory Management- Home-based, EMEA

    hace 2 semanas

    Madrid, España IQVIA A tiempo completo

    Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

  • Regulatory Affairs Manager

    hace 4 semanas

    Madrid, España Ergomed A tiempo completo

    Company Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...

  • translation qc junior project manager – regulatory submissions

    hace 2 días

    Madrid, Madrid, España IQVIA A tiempo completo

    TRANSLATION QC JUNIOR PROJECT MANAGER – REGULATORY SUBMISSIONSWorking with the Regulatory Submissions Project Management team, the Translation QC Project Manager – Regulatory Submissions is responsible for coordinating and performing the QC step for the Regulatory Submissions translation and localization projects whilst ensuring IQVIA's standards are...

  • Associate Manager, Clinical Trials Regulatory Management- Home-Based, Europe

    hace 3 semanas

    Madrid, España Sdi Digital Group A tiempo completo

    Prepares and / or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complexAbility to administratively and technically / scientifically review core scientific documentation...

  • Regulatory and Start Up Manager

    hace 8 horas

    Madrid, España IQVIA A tiempo completo

    Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Fluent in Spanish and English. Essential Functions Oversee the execution of Site Activation...

  • Compliance Manager Spain and Italy

    hace 6 días

    Madrid, España CMC Markets A tiempo completo

    Role & Responsibilities - Management of the Compliance function for Spain and Italy, ensuring there is a robust and proportionate systems and controls framework in place to manage regulatory risk, including in relation to the prevention of financial crime - The Compliance Manager - Spain & Italy, will act as Deputy MLRO for the Spain Branch before Sepblac. -...

  • Regulatory Affairs Manager

    hace 3 semanas

    Madrid, España IQVIA A tiempo completo

    The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...