Regulatory Affairs Manager CMC

Oxford Global Resources; Barcelona; Presencial; EUR 70 000 - 90 000; Tempo integral

Resumo da oferta

A leading consulting firm is seeking a Global CMC Regulatory Affairs Manager Consultant to support a top pharmaceutical company in Barcelona. This role offers the opportunity to provide regulatory insight, author CMC documents, and coordinate activities for market expansion. The ideal candidate will have at least 5 years of experience in regulatory affairs, a Bachelor's degree in Life Sciences, and fluency in English. This full-time position involves collaboration across multiple teams to ensure compliance with global regulatory requirements.

Qualificações

• Minimum 5 years in Regulatory CMC field for pharmaceutical products at a global level.
• Good knowledge of international CMC regulatory legislation.
• Demonstrable submission history experience for EU and other international territories.

Responsabilidades

• Provide CMC regulatory insight and advice to multidisciplinary teams.
• Author CMC documents for submission to Health Authorities.
• Coordinate CMC regulatory activities for market expansion.

Conhecimentos

Fluency in English for business communication

Strategic regulatory mindset

Strong scientific and technical CMC knowledge

Collaboration with CMOs and Health Authorities

Formação académica

Bachelor’s degree in Life Sciences or related field

Descrição da oferta de emprego

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 headquarters 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.

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Science, Research, and Project Management

Industries

• Pharmaceutical Manufacturing, Biotechnology Research, and Business Consulting and Services

Location: Greater Barcelona Metropolitan Area