Regulatory Affairs Operations Lead

About the position

A pharmaceutical client is looking for a Regulatory Affairs Operations (RegOps) Lead  that will responsible for overseeing Regulatory Operations activities and strategic initiatives in support of pre- and post-approval filing as well as ongoing document maintenance efforts within their OTC division.
Qualifications 

• Pharmacy Bachelor’s 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 SOP’s 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

Desired Skills:

• ms-office suite
• document management
• eCTD