Regulatory Affairs Manager (CMC Biologics)
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Our new office location in La Barceloneta has multiple opportunities available for experienced Regulatory Affairs Managers. We are growing our teams on a global basis;
there has never been a more exciting time to join us!
Do you want to help bring life-changing medicines to the world?
Are you passionate about science, strategy, and regulatory excellence?
As a CMC Regulatory Manager, you'll play a key role in ensuring that high-quality medicines continue to reach patients safely and efficiently across global markets.
You'll sit at the intersection of science, manufacturing, and regulatory strategy, guiding post-approval activities and ensuring that every change to our products meets global regulatory standards.
If you enjoy solving complex problems, working across teams, and translating technical data into clear regulatory strategies, this role is for you.
The Role
- Develop and implement regulatory strategies for post-approval CMC activities, including: Variations, Renewals, Market expansions, Annual reports
- Review change controls and assess how manufacturing or quality updates impact regulatory filings.
- Working on Regulatory classification of changes, Submission requirements, Global regulatory impact
- Collaborate with quality and manufacturing teams to review key reports such as: Process validation studies, Stability studies, Analytical method validation
- Draft and review CMC sections of regulatory documents, including: Variation submissions, Responses to health authority questions, Technical regulatory documentation
- Oversee projects within Regulatory Information Management (RIM) systems, ensuring global submissions are tracked, maintained, and compliant.
- Identify potential regulatory challenges early and implement strategies to keep projects on track.
Requirements
What we are looking for:
- Demonstrable experience working with Biologics or Vaccines
- Experience in Regulatory Affairs within the pharmaceutical industry
- Strong background in CMC or technical regulatory documentation
- Experience preparing CMC sections of regulatory submissions or variations
- Experience in validation, quality assurance, or pharmaceutical production is highly valued
Technical Knowledge
- Strong understanding of CMC and post-approval regulatory requirements
- Knowledge of Stability studies, Process validation, Analytical method validation, Comparability studies
- Experience working with Biological products or vaccines is a mandatory requirement for this role.
Skills
- Exceptional attention to detail
- Strong problem-solving ability
- Excellent project management skills
- Ability to collaborate with cross-functional global teams
Languages
- Fluency in English (written and spoken)
- Additional language (French, Italian, or German) is a plus
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. xqysrnh
We recruit based on talent alone and firmly believe that an individual's background should play no part in the recruitment and selection process.