Reporting to the Manager of Regulatory Affairs, the Associate of Regulatory Affairs will be responsible for all aspects of Regulatory including but not limited to the responsibilities and duties described below:
Key Responsibilities and Primary Duties
Key Responsibility: Regulatory Affairs (90%)
- Assist in preparation of pre-market and post-market dossiers for drugs for submission to regulatory authorities in North America, with main focus on Canada.
- Review, analyze, interpret and provide guidance on relevant technical documents from development sites and provide regulatory guidance to internal and external partners.
- Prepare, review and approve product labels and promotional materials.
- Prepare and track formulary submissions and listings as required
- Ensure post approval regulatory compliance of marketed drug products meeting company and regulatory requirements.
- Assist in due diligence activities when necessary
Key Responsibility: Quality Assurance Support (10%)
- Support efficient and timely release of products to the marketplace and establish and maintain quality standards and related policies for all finished products.
- Support to establish and enforce Good Manufacturing and Quality Control Procedures.
- Liaise with internal and external partners to ensure compliance with product approvals, regulatory requirements, and GMPs
- Assists in the development and implementation of Quality Assurance programs and projects including the management of SOPs, change controls, document management and investigations, and annual product reviews.
Qualifications & Skills
Education Requirements: B.Sc. in chemistry, pharmacy or another life science.
- 3-5 Years experience as a Regulatory Affairs Professional. Experience with parenteral products preferred.
- Knowledge of TPD, FDA and ICH guidelines, GMPs, regulations and other relevant policies.
- Strong communication skills (written and verbal).
- Ability to multi-task, remain flexible, manage priorities, and adhere to deadlines.
- Results oriented with a proven ability to prioritize work and meet challenging deadlines.
- Quick Learner with ability to work in a fast paced and changing environment.
- Demonstrated ability to remain calm under pressure.
- Proficiency in MS Word, Excel, Access, Sharepoint, Outlook and Internet.
This description outlines the principal functions of the job identified and should not be considered a detailed description of all requirements that may be inherent in the job.