Regulatory Affairs Specialist
1 day ago
ClinChoice Inc. is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.
Job OverviewWe are seeking an experienced Regulatory Affairs Manager to join our team in the Consumer Health OTC medicines department. As a Regulatory Affairs Manager, you will be responsible for managing regulatory submissions, developing regulatory strategies, and ensuring compliance with EU regulations and guidelines.
Key Responsibilities:- Manage regulatory submissions for OTC medicines, including preparation of marketing authorizations and responses to regulatory agency questions.
- Develop and implement regulatory strategies for Consumer Health OTC medicines, ensuring compliance with EU regulations and guidelines.
- Provide regulatory advice and support to internal stakeholders, ensuring that all regulatory obligations and business objectives are met.
- Collaborate with cross-functional teams to ensure that regulatory requirements are met throughout the product lifecycle.
- Maintain awareness and knowledge of current regulatory legislation, ensuring that all team members are aware of any changes or updates.
To be successful in this role, you will need:
- A degree in Life Sciences or Chemistry, Honours level or equivalent, with 8-10 years of work experience in Regulatory Affairs in OTC products.
- Excellent communication and project management skills, with the ability to work with minimal supervision.
- Strong technical knowledge of regulatory requirements and procedures, with the ability to develop and implement effective regulatory strategies.
The estimated salary for this position is $120,000 - $150,000 per year, depending on experience.
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