Regulatory Affairs Consultants, CMC Full time Mumbai, India
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 solutions.
As demand for our services and solutions continues to increase, we have multiple openings in our Indian team for Regulatory Affairs professionals with CMC experience.
As part of G&L’s permanent team of CMC professionals, the successful candidate will be working on a variety of post-approval client projects.
Typical duties would include:
- Preparing CMC 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.
- Working in EU and ROW regions.
- Expediting submissions, reviewing and approving global CMC applications.
- Contributing to marketing authorization applications.
- Managing multiple projects simultaneously; provide 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 CMC Regulatory processes, policies and systems.
- Contributing to process improvement and regulatory intelligence projects.
- Must have a minimum of 5 years working experience in Post Approval CMC.
- Must have personal experience authoring documentation from scratch.
- Must have impeccable communication skills (written and spoken) and be comfortable presenting over video call.
- Previously experience working for a consultancy company would be a benefit.
- Small molecule/pharmaceutical experience, ideally across multiple therapy areas.
- CMC authoring experience essential (previous coordination role is not sufficient), including authoring Module 3 and CMC variations.
- Must be willing to work at G&L’s office location in Mumbai for part/all of the week
For further details, please send your CV to: firstname.lastname@example.org
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.
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- Contract Type:
Full Time Career Opportunity
Mumbai, Maharashtra, India
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