Senior Regulatory Affairs Executive, Regulatory Affairs
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.
As demand for our services and solutions continues to increase, we have an exciting opportunity for a Senior Regulatory Executive to join our team in Mumbai, India.
This role will commence in December 2022.
As part of G&L’s permanent team of RA professionals, the successful candidate will be working on a variety of client projects.
Typical duties will include:
- 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 guidance.
- Contributing to marketing authorization applications.
- Managing multiple projects simultaneously; providing data assessment and conclusions.
- Identifying risks associated with submission data and information packages and then proposing mitigation plans.
- Efficiently interacting with customers and senior stakeholders as required.
- Identifying improvement opportunities for Regulatory processes, policies and systems.
- Contributing to process improvement and regulatory intelligence projects.
- 4-8 years of working experience in Regulatory Affairs.
- Previous experience working for a consultancy company would be a benefit.
- Small and large molecule experience, ideally across multiple therapy areas/dosage forms
- Impeccable communication skills and flexible approach; diplomacy and negotiating skills.
For further details, please send your CV to: email@example.com
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.
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