Regulatory Affairs Director
5 days ago
We are seeking an experienced Regulatory Affairs Director to lead our team in developing and implementing effective regulatory strategies for our pharmaceutical products in Canada.
Main Responsibilities:- Develop and implement Canadian registration/regulatory strategies to ensure compliance with Health Canada regulations.
- Lead and chair Health Canada meetings, preparing meeting-related materials and logistics.
- Plan and prepare regulatory submissions (NDSs, SNDSs, CTAs, NCs, Level IIIs) to meet designated timelines.
- Maintain close communications and good working relationships with Health Canada, internal cross-functional partners, and Global colleagues.
- Manage development and implementation of regulatory strategies for marketed and developmental products.
- Cross-functionally work with various departments, including marketing and sales, to identify business opportunities based on regulatory changes.
- Support identification and evaluation of potential regulatory risks, ensuring alignment with corporate objectives.
- Prepare Product Monograph updates for labelling compliance and support artwork label updates.
- Maintain SOPs across Regulatory related functional areas.
- Bachelor's or Master's degree in life sciences or related field (e.g. pharmacology, toxicology, chemistry).
- Regulatory Affairs Certificate preferred.
- Approximately 5+ years of experience in pharmaceutical Regulatory Affairs.
- Mandatory regulatory prescription experience.
- Exceptional communication, interpersonal, and organizational skills.
- Strong leadership skills for cross-functional collaboration.
- Ability to manage multiple priorities in a fast-paced environment.
- Excellent written, verbal, and presentation skills.
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