CMC Team Leader (big pharma)en Barcelona.
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Patricia Felipe
Contactarour client
We're currently seeking a talented CMC RA Coordinator to join an innovative big pharma company located in the metropolitan area of Barcelona within its OTC business unit!
ver menosyour functions
- Support the development of the CMCD (Chemistry, Manufacturing, and Controls Development) strategy for certain products of the business unit, both mature and new launch, to ensure globally approvable dossiers.
- Responsibility is shared across global and local markets.
- Work closely with Regulatory to develop effective Regulatory and CMC strategies.
- Collaborate with R&D, Product Supply, and Regulatory to ensure the timely compilation of high-quality CTD Module 3 and QOS documents.
- Support responses to Quality questions from Regulatory Health Authorities.
- Support the core Technical Sub Teams from feasibility, through all clinical stages, license application, and post-approval LCM.
- Effectively manage post-approval change and product lifecycle.
- Drive continuous improvement.
- Maintain and implement knowledge of current industry requirements and best practices for CTD Module 3 and QoS or equivalent.
position requisites
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Formación
: Licenciado: Ciencias Químicas -
Idiomas
: Inglés: C1 -
Conocimientos
: gmp, glp, gdp, gcp -
Experiencia
: 4 años
Academic background in life sciences.
Very high proficiency in spoken and written English, as this is a global position.
Significant experience in CMC/Module 3 creation and response to questions.
Experience in QA and RA departments for global markets, including but not limited to North America, South America, Europe, Australia, ASEAN, and the Middle East.
Experience leading projects in the QA department.
Experience managing teams.
your benefits
Attractive compensation package with extensive social benefits.
Hybrid position with great flexibility.
You will belong to a leading big pharma company in its sector.
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!
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