Junior Cmc Technicianen Barcelona.
detalle oferta
¿tienes alguna duda?
Amplía la información sobre el proceso contactando con:
Ana Rullan Janer
ContactarThe Global CMC Regulatory Affairs professional is a critical strategic role responsible for defining, developing, and executing the global regulatory strategy for the Chemistry, Manufacturing, and Controls (CMC) aspects of assigned pharmaceutical or biological products throughout their lifecycle¿from early development through post-approval.
our client
Global CMC Regulatory Affairs
ver menosyour functions
- Lead and develop innovative global CMC regulatory strategies to ensure optimal development, registration, and lifecycle management of assigned products, balancing business objectives with regulatory compliance.
- Serve as the primary CMC regulatory subject matter expert (SME) on global project teams, providing clear, decisive guidance on regulatory risks and requirements.
- Interpret and apply global CMC regulations and guidelines (ICH, FDA, EMA, etc.) to all manufacturing and quality-related activities.
- Assess the regulatory impact of proposed manufacturing changes (e.g., process changes, site transfers, specification updates) and define the optimal global regulatory filing strategy for timely implementation.
- Oversee, author, review, and coordinate the preparation of high-quality CMC sections (Modules 2.3 and 3) for major global regulatory submissions.
position requisites
-
Formación
: Licenciado: Ciencias Químicas -
Idiomas
: Inglés: C1 -
Conocimientos
: gmp, glp, gdp, gcp -
Experiencia
: 4 años
- Bachelor's degree in a relevant scientific discipline (e.g., Chemistry, Pharmacy, Chemical Engineering, Biology). An advanced degree (Master's or Ph.D.) is preferred.
- A minimum of 3 years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Proven track record of successfully preparing, authoring, and managing major global CMC submissions (IND/CTA/IMPD and NDA/BLA/MAA).
- Exceptional written and verbal communication skills in English for authoring complex scientific documents and negotiating with external parties.
- Demonstrated leadership and negotiation skills to influence cross-functional teams and regulatory bodies.
your benefits
Salary commensurate with experience and expertise
Work Flexibility: Opportunity to remote work.
Access to continuous learning programs, conferences, and career development opportunities.
why with Randstad?
Because we have thousands of job offers in our portal.
Because we work with the best companies offering you the best jobs.
Because we assure you all the legal guarantees in your hiring.
Because we guarantee a close follow-up after your incorporation, because we want you to be satisfied.
Because we put at your disposal our advanced technology so that you can sign your contracts and access your labor documentation in a single click.
Because we always count on you.
Enroll in this offer, you will be part of the Randstad candidate database for future employment opportunities.
Register now and find the job you are looking for!
sustainable jobs
Randstad’s ambition is to be the world’s most equitable and specialized talent company. We help talent and organizations unlock their true potential by seeking responsible opportunities that drive long-term economic sustainability, prioritizing the well-being of people and the planet.
we are sustainable employment
Our conviction that all talent, regardless of their background, has equal opportunities for success is evident in our processes, in which we promote workplace equity through diverse and inclusive teams.
commitment NetZero
We strengthen our environmental commitment to achieve carbon neutrality by 2050 through the Science Based Targets initiative (SBTi).
