Regulatory Affairs Operations Lead

Qualifications

Pharmacy Bachelors degree or equivalent in life sciences or technology-related discipline

Grade 12

Experience

Minimum 2 years Regulatory Operations experience required.

5 years pharmaceutical industry experience, with prior Regulatory Operations experience required.

Experience leading the management of projects/timelines and collaborating with team members

Expertise in the use of a document management, eCTD format and regulatory submission requirements and eCTD publishing systems

Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems

Previous experience developing work instructions and generating SOPs that are consistent with health authority requirements and company business practices

Proven ability to manage, streamline and collaborate to improve document preparation and management systems

Core competencies

Advanced technical skills in best business practices for electronic regulatory document preparation and submission, and document and life cycle management systems

Excellent negotiation and relationship development skills to effectively interact with vendors and partners

Demonstrated advanced leadership, problem solving and organizational skills

Excellent oral and written communication skills

An ability to be productive and successful in an intense work environment

Knowledge of industry trends regarding electronic submissions.

Technical knowledge of electronic publishing systems and software.

Proficiency with MS-Office Suite and Adobe Acrobat application

Must demonstrate responsibility, excellence and collaboration and align with Company values