Regulatory Affairs Associate/Senior Associate
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.
We are currently building a team to work in partnership with a major biopharma company in Canada which has requested our support in all aspects of their Regulatory Affairs documentation preparation.
To fulfil this, we are delighted to be recruiting multiple Regulatory Affairs professionals to join our teams in Montréal and Toronto.
A day in the life of one of our consultants can be varied and unpredictable. These opportunities are ideal for those who thrive when busy, enjoy guiding clients through complex regulatory strategies and are completely solutions-orientated.
- Managing regulatory submissions to Health Canada (NDS, S/NDS, NC) for both small molecules and biosimilar products.
- Producing Regulatory strategy for drug submissions and product life cycle maintenance (prescription and consumer health products).
- Providing Regulatory consulting services for GAP assessments and/or due diligence for new product dossiers
- Assisting with product life cycle management.
- Providing Regulatory advice and strategy.
- Product label development, reviewing and updating (Product Monograph, information for the Consumer product labels) for the Canadian market.
- Producing clinical submissions, chemistry and manufacturing submissions.
- Producing DIN submissions, and OTC submissions.
- Working closely with G&L’s Regulatory Operations team to provide eCTD publishing activities.
- Handling CPP requests.
- Previous experience in a Regulatory Affairs role: (pharmaceutical and/or biologics with regulatory experience in the local environment is preferred).
- Junior Associate 1-3 years,
- Associate 3-5 years,
- Senior Associate 5-8 years
- Expertise in ANDS submissions more specifically M1, M2, M3 and M5 assessment.
- Ability to prepare submission documents independently.
- Ability to interpret applicable statutes, regulations and guidance documents required to prepare regulatory submissions and develop regulatory strategy with guidance.
- Knowledge of applicable laws, regulations and guidance documents required to prepare regulatory submissions with guidance.
- Previous experience working with Health Canada
- Fluent in English and ideally French.
- Excellent communication and negotiation skills.
- Excellent eye for detail and a high level of accuracy in all work produced.
- Ability to work independently and with a team.
- Ability to multitask and manage several submissions at different stages.
- Problem-solving, judgment and decision-making skills to seek creative solutions to issues surrounding on-time, on-budget and high-quality project outcomes.
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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