Regulatory Manager

hace 8 meses

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 European locations.

As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.

Primary Tasks & Responsibilities:

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.

Assess change controls and provide regulatory assessments of quality changes in production and quality control.

Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.

Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.

Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.

Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.

Identify, escalate, and mitigate risks associated with regulatory procedures and activities.

Experience and Knowledge Requirements:

University-level education, preferably in Life Sciences, or equivalent by experience.

Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.

Strong understanding of CMC and post-approval regulatory requirements.

Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.

Knowledge of biological processes.

Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.

Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.

Team spirit, flexibility, accountability, and organizational skills.

Fluent in English (written and spoken). French, Italian and German would be a strong plus.

  • Regulatory Manager

    hace 6 meses

    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...

  • Regulatory Manager

    hace 6 meses

    Madrid, España Precision for Medicine A tiempo completo

    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....

  • Regulatory Compliance Manager

    hace 1 mes

    Madrid, Madrid, España Six Group Services Ltd. A tiempo completo

    About the Role: We are seeking a Regulatory Compliance Manager to join our team in Zurich. As a key member of our regulatory team, you will be responsible for monitoring regulatory developments and ensuring compliance for SIX Clearing across the EU, ES, CH, and UK.Key Responsibilities:Monitor regulatory changes in CCP regulations across EU, ES, CH, and UK,...

  • Regulatory Cmc Manager

    hace 2 semanas

    Madrid, España Tfs Healthscience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory Cmc Manager

    hace 2 semanas

    Madrid, España Tfs Healthscience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory Affairs Manager

    hace 3 semanas

    Madrid, Madrid, España Oatly A tiempo completo

    Oatly, the original oatmilk company, is expanding its presence in North America and seeks a highly skilled Regulatory Affairs Manager to join our team. As the leader of our US-based regulatory affairs function, you will provide expert guidance on food law and compliance matters.About the Role:This role involves leading the Oatly North America Regulatory...

  • Regulatory Cmc Manager

    hace 2 semanas

    Madrid, España Tfs Healthscience A tiempo completo

    TFS Health Science is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey.We provide full-service capabilities , resourcing , and Functional Service Provider (FSP) solutions , helping bring life-saving treatments to patients worldwide.Sponsor:...

  • Regulatory Writing Senior Manager

    hace 3 semanas

    Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo

    Senior Regulatory Writing ManagerWe are seeking an experienced Regulatory Writing Senior Manager to join our team at Syneos Health.In this role, you will be responsible for managing medical writing activities and ensuring compliance with regulatory requirements.This is an exciting opportunity to work with a dynamic team and contribute to the development of...

  • Regulatory Cmc Manager

    hace 2 semanas

    Madrid, España buscojobs España A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory Cmc Manager

    hace 1 semana

    Madrid, España buscojobs España A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory CMC Manager

    hace 2 semanas

    Madrid, España TFS HealthScience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory CMC Manager

    hace 1 semana

    Madrid, España TFS HealthScience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory CMC Manager

    hace 3 semanas

    Madrid, España TFS HealthScience A tiempo completo

    TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. We provide full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, helping bring life-saving treatments to patients worldwide.Sponsor: You...

  • Regulatory Compliance Manager

    hace 3 semanas

    Madrid, Madrid, España Monex Europe Limited A tiempo completo

    **Monex Europe Limited: A Leading Foreign Exchange Provider**We are a commercial foreign exchange provider and authorised by the Bank of Spain as a payment services firm to passport our services across the EEA.Key Responsibilities:The Regulatory Compliance Manager ensures our firm operates in compliance with BoS and CNMV regulations.Work closely with the...

  • Regulatory Compliance Manager

    hace 4 meses

    Madrid, España Dojo.tech A tiempo completo

    ES Madrid | Legal & Compliance Ireland | 21 Aug 2024 | R-0003633 **Diversity, equity, and inclusion at Dojo**: From local bakeries to well-known eateries, Dojo payments serve over 140,000 places across the UK. And something that’s fundamental to creating relevant, innovative products at Dojo is to build teams to reflect the diversity of the businesses...

  • Regulatory Affairs Manager

    hace 4 semanas

    Madrid, España Astrazeneca Gmbh A tiempo completo

    .Regulatory Affairs Manager Location: London St Pancras Competitive salary, bonus & benefits Join our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product...

  • Regulatory Affairs Manager

    hace 4 semanas

    Madrid, España Astrazeneca Gmbh A tiempo completo

    Regulatory Affairs Manager Location: London St PancrasCompetitive salary, bonus & benefitsJoin our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product...

  • Regulatory Affairs Manager

    hace 4 semanas

    Madrid, España Astrazeneca Gmbh A tiempo completo

    .Regulatory Affairs ManagerLocation: London St PancrasCompetitive salary, bonus & benefitsJoin our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product...

  • Regulatory Compliance Manager

    hace 3 meses

    Madrid, España dojo A tiempo completo

    Diversity, equity, and inclusion at DojoFrom local bakeries to well-known eateries, Dojo payments serve over 140,000 places across the UK. And something that’s fundamental to creating relevant, innovative products at Dojo is to build teams to reflect the diversity of the businesses we serve.Our drive to improve diversity, equity, and inclusion is closely...

  • Senior Manager, Regulatory Affairs

    hace 2 semanas

    Madrid, España Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...