Regulatory Affairs Executives

hace 6 días

Barcelona, España G&L Scientific A tiempo completo

**About Us**:
G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.

This is an opportunity to join our growing team in Europe as we are seeking multiple Regulatory Affairs Executives in Barcelona.

**The Role**:

- Preparing 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 guidance.
- Efficiently interacting with clients and senior stakeholders as required.
- 2-3 years of generalist regulatory experience, in small and/or large molecule products, consumer healthcare, and/or animal health products.
- Experience in European procedures, emerging markets and international regions.
- Previous experience of working on CMC for Small Molecules & Biosimilars.
- A natural aptitude for project management, working to deadlines and dealing with a large volume of different country-specific requirements.
- Experience in paper and electronic regulatory submissions. This should include the coordination and execution of publishing solutions that meet the unique requirements of each submission and the management of product delivery to regulatory agencies.
- The ability to liaise with internal colleagues and client stakeholders to ensure submission requirements and timelines are mutually understood and in line with standards and deadlines for dossier delivery to regional markets.
- Excellent communication skills are essential, as are diplomacy and negotiation skills.

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.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from the threat of discrimination, intimidation, harassment, and abuse.

All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity
- Contract Type: Permanent Career Opportunity
- Location: Barcelona, Spain

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