Regulatory Affairs Cmc Manager

hace 4 semanas

Barcelona, España Barrington James A tiempo completo

Barcelona, Spain
- 19-06-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- Regulatory Affairs
- SALARY TYPE
- Annually
- SALARY
- Negotiable

Job Description: Regulatory CMC Manager - Permanent

Location: Barcelona, Spain

Overview:
A leading global pharmaceutical company committed to advancing healthcare, is seeking a highly motivated and experienced Regulatory CMC (Chemistry, Manufacturing, and Controls) Specialist to join our team in Spain. As a Regulatory CMC manager, you will play a crucial role in ensuring compliance with regulatory requirements related to the development, registration, and lifecycle management of our medicinal products. Your expertise in CMC will contribute to the success of our global regulatory strategies and enable us to bring safe and effective therapies to patients worldwide.

**Responsibilities**:

- Regulatory Strategy: Collaborate with cross-functional teams to develop and execute global regulatory CMC strategies for new drug development programs, including preclinical, clinical, and commercial stages.
- Regulatory Submissions: Prepare, review, and compile high-quality CMC sections for regulatory submissions (e.g., IND, NDA, MAA), ensuring compliance with regional requirements and guidelines (e.g., FDA, EMA, ICH).
- Compliance and Documentation: Provide guidance on CMC-related regulatory requirements and ensure adherence to Good Manufacturing Practices (GMP) and other relevant regulations. Review and maintain technical documentation, including batch records, stability data, and manufacturing process documents.
- Health Authority Interactions: Act as the primary point of contact for regulatory CMC matters during interactions with health authorities, responding to inquiries and addressing regulatory queries efficiently and effectively.
- Change Control: Assess and manage changes to manufacturing processes, analytical methods, and specifications, ensuring regulatory compliance and appropriate documentation throughout the change control process.
- Regulatory Intelligence: Monitor and analyse CMC-related regulations, guidelines, and industry trends to proactively identify potential impact on development programs or marketed products. Share insights and recommendations with relevant stakeholders.
- Cross-Functional Collaboration: Work closely with internal teams, including R&D, Quality Assurance, Manufacturing, and Supply Chain, to ensure alignment of regulatory CMC activities with overall business objectives.
- Training and Support: Provide CMC regulatory guidance and training to internal stakeholders, ensuring awareness and understanding of regulatory requirements and best practices.

Qualifications:

- Bachelor's or advanced degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field. Advanced degree is preferred.
- Minimum of 4-5 years of relevant experience in regulatory affairs, specifically in CMC, within the pharmaceutical industry.
- Comprehensive knowledge of global regulatory guidelines and requirements, including FDA, EMA, and ICH guidelines, as well as GMP regulations.
- Proven track record in preparing and submitting CMC sections of regulatory filings (e.g., IND, NDA, MAA) in compliance with regional requirements.
- Strong understanding of pharmaceutical development processes, manufacturing operations, and analytical techniques.
- Excellent communication skills, both written and verbal, with the ability to effectively interact with internal teams, external partners, and health authorities.
- Detail-oriented approach with a focus on quality and compliance.
- Ability to prioritize and manage multiple projects simultaneously while meeting deadlines.
- Proficiency in English and Spanish. Additional language skills would be a plus.

Be part of a dynamic and innovative organisation dedicated to improving patients' lives through the development of high-quality pharmaceutical products. As a Regulatory CMC Specialist, you will have the opportunity to contribute to the success of our regulatory strategies, ensuring compliance and facilitating the global registration and availability of our medicines.

Consultant
- Tomas Swithenbank
- +441293776644

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