Regulatory Affairs Manager Cmc
hace 4 semanas
Barcelona, Spain
- 19-06-2023
- JOB TYPE
- Contract
- EMP TYPE
- Full-Time
- EXPERTISE
- Regulatory Affairs
- SALARY TYPE
- Hourly
- SALARY
- Negotiable
Job Description: Regulatory CMC Manager - Contract
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
-
Regulatory Affairs Cmc Manager
hace 4 semanas
Barcelona, España Barrington James A tiempo completoBarcelona, 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...
-
International Cmc Regulatory Affairs Director
hace 5 días
Barcelona, España AstraZeneca A tiempo completoWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, working together to turn the impossible into reality. If you are action-oriented, confident in leadership, collaborative, and curious about the potential of science, then you are the perfect fit for us. Join our Chemistry,...
-
Regulatory Affairs Manager
hace 5 días
Barcelona, España AstraZeneca A tiempo completoAt AstraZeneca, we're not just about treating diseases - we're about defeating them. We're on a mission to turn innovative science into life-changing medicines, and we need your help. As a Reg Affairs Manager in our Oncology R&D department, you'll play a crucial role in gaining approval for our novel work on unmet medical needs. If you're ready to make a...
-
Regulatory Affairs Associate Director
hace 5 días
Barcelona, España AstraZeneca A tiempo completoWelcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, big dreamers, and collaborators who work together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...
-
Manager, Regulatory Affairs
hace 1 mes
Barcelona, España G&L Healthcare Advisors A tiempo completoContract: Permanent Career Opportunity Closing Date: 10/02/23 **The Role**: - The preparation of CMC regulatory documents and/or other regulatory documents for MAA and Post Approval Lifecycle projects including renewals, variations, annual reports etc. - Working with manufacturing sites on change control projects; providing regulatory advice and strategic...
-
Regulatory Affairs Manager
hace 2 semanas
Barcelona, España Robert Walters A tiempo completoRobert Walters is hiring a Regulatory Affairs Manager in Barcelona. Our client is an important pharmaceutical company specialized in medical nutrition. As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the...
-
Regulatory Affairs Manager
hace 2 semanas
Barcelona, Barcelona, España Robert Walters A tiempo completoRobert Walters is hiring a Regulatory Affairs Manager in Barcelona.Our client is an important pharmaceutical company specialized in medical nutrition.As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the...
-
Regulatory Cmc Operations Manager
hace 1 mes
Barcelona, España NonStop Consulting A tiempo completoI am actively seeking a Regulatory CMC Operations Manager for a medium-sized pharmaceutical company who is rapidly growing. This strategic position is ideal for someone who thrives in a hands-on environment, and loves to challenge themselves, while growing with the company to develop their career even further. In this hands-on position you will be working...
-
RA-CMC Specialist
hace 4 semanas
Barcelona, España Galderma A tiempo completoDescription We are looking for an expert in Regulatory Affairs for preparing and updating the CMC (Chemistry, Manufacturing and Control) dossier sections of assigned products (Rx or non-monograph OTC drugs). This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities. Key Responsibilities...
-
Regulatory Affairs
hace 1 mes
Barcelona, España Hays A tiempo completo**Tu nueva empresa** Nuestro cliente es una empresa en pleno crecimiento que se dedica a la investigación de ingredientes patentados para su aplicación en diferentes sectores: alimentación, salud y nutrición. **Tu nuevo puesto** Estamos buscando perfiles como Regulatory Affairs Manager & Regulatory Affairs Technician, cuyo objetivo será el de...
-
ra-Cmc Specialist
hace 2 días
BARCELONA, España GALDERMA A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Quality Assurance
hace 1 semana
Barcelona, España Winid A tiempo completoQuality Assurance & Regulatory Affairs Manager Winid is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to...
-
Regulatory Affairs Technician
hace 1 mes
Barcelona, España Oxford Global Resources A tiempo completoOxford Global Resources buscamos a un Regulatory Affairs para una empresa líder farmaceútica. Responsabilidades:Compilación y redacción de documentación CMC (Química, Fabricación y Controles) para las solicitudes de nuevos expedientes de registro, así como la gestión de los trámites regulatorios con las autoridades sanitarias correspondientes...
-
RA-CMC Specialist
hace 1 día
Barcelona, España Galderma A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Consultant Ra Qa
hace 1 día
Barcelona, España Clarivate Analytic A tiempo completoWe are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing...
-
Regulatory Affairs Director
hace 1 mes
Barcelona, España Consult Search A tiempo completo**Scope**: Director of regulatory affairs position that has been opened to further accompany the growth of the company on this sector. Although our client is a historically pharma oriented manufacturer, they have in the recent years expanded their activities in the Medical Aesthetics area, with products currently on market in the Dermal and Hyaluronic acid...
-
Regulatory Affairs Manager
hace 1 mes
Barcelona, España Centrient Pharmaceuticals Netherlands A tiempo completoCentrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms. We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our...
-
Regulatory Affairs Manager
hace 4 semanas
Barcelona, España Innovaderm Research A tiempo completoThe Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm’s standard operating procedures, applicable regulations and good clinical practices and to the Sponsor’s satisfaction. Responsibilities include providing leadership on regulatory activities...
-
Regulatory Affairs
hace 1 mes
Barcelona, España Hays A tiempo completo**Tu nueva empresa** Reconocido Laboratorio Farmacéutico ubicado a escasos KM de Barcelona. **Tu nuevo puesto** Precisamos incorporar un perfil de Regulatory Affairs - Técnico de Registros Tus funciones serán las siguientes: - Elaborar, mantener y actualizar los dossiers de los medicamentos y los expedientes técnicos de los productos de la...
-
Regulatory Cmc Liaison Manager
hace 1 mes
Barcelona, España NonStop Consulting A tiempo completoI am actively seeking an experienced RA professional with excellent communication skills and a business mind-set who will provided value-added input to internal stakeholders and clients for a medium-sized pharmaceutical company located in Basel that is growing rapidly. In this exciting and challenging position you will take full responsibility for your...