Manager/Senior Manager, 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 new opportunity for a Manager/Senior Manager to join our North American team.
This role has responsibility for a wide variety of CMC duties to support G&L’s range of pharma and biopharma clients, including:
- Prioritizing and completing multiple projects within established time frames.
- Managing client projects, including managing working relationships with various stakeholders across our organization and our clients.
- Providing G&L clients with CMC, regulatory and quality support for pharmaceutical programs.
- Managing client regulatory filings on mandated timelines for scientific content and adherence to regulator guidance for application integrity.
- Completing gap assessments on client filings, meeting requests and packages, etc.
- Life Sciences degree.
- Advanced level in written English, intermediate level in spoken English.
- A minimum of ten (10) years of relevant experience in a Regulatory CMC role.
- Comprehensive experience in Canadian CMC, including knowledge of current guidelines in Canada.
- Good knowledge of Canadian legislation and Biologics experience are an asset.
- Good knowledge of the drug development process, regulatory affairs, and regulatory operations activities with a quality approach to documentation.
- Sound written and oral communication skills, good organizational and planning skills.
- Strong computer skills.
- An impeccable eye for detail.
- Ability to build positive, productive relationships with colleagues and clients.
- Ability to speak and write French is an asset.
- Ability to work flexibly and demonstrate an agile and positive approach to project work.
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.
All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
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