Apotex
Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Job Title: Sr. Associate/Associate-Regulatory Affairs
No. of Posts: 1
Job Description:
- Responsible for the preparation and peer review of quality regulatory submissions for various markets to ensure timely approval
- Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets
- Accountable for assessing, coordinating and compiling deficiency responses received from regulatory authorities and customer queries in a timely manner
- Compilation of Site Registration Applications
- Works with other functional areas, including counterparts in Toronto, to resolve issues related to information for regulatory submissions
- Evaluate, prepare and peer review of post approval changes to manage the regulatory product life cycle as applicable
- Review and approval of change control documents till product launch
- Preparation, review and maintenance of approval notification packages
- Maintain regulatory databases to ensure accuracy of information
- Perform additional duties as assigned by Team Leader / Sr. Manager
- Works as a member of a team to achieve all outcomes
- Perform all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
- Perform all work in accordance with all established regulatory and compliance and safety requirements.
- All other duties as assigned.
- Relationship with Internal / External Customers and Stakeholders
- Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and / or problems
- Communicate with external sources such as agents / customers / suppliers to request and / or provide data relevant to submissions
- Contribute to the creation and promotion of an environment of teamwork and empowerment
- Problem Solving Analysis
- Resolve complex issues relating to submissions
- Decision making / autonomy
- Makes complex interpretation and application decisions relating to regulatory guidelines and policies
- Leadership / Professional Development of self and others
- Address complex regulatory activities in support of submissions
- Assist in training of more junior staff
- Seeks guidance from other team members to enhance regulatory knowledge
- Compliance and Due Diligence
- Interpret and ensure compliance with SOPs, RA policies and procedures and regulatory guidelines
- Prepare and / or draft SOPs and regulatory guidelines
Qualifications:
- A post graduate/ graduate degree or equivalent in Life Sciences / Pharmacy from a recognized school
- Minimum 5-8 years of experience in RA role
- Good oral / written communication, organizational and interpersonal skills
- Attention to detail
- Demonstrates leadership skills
- Computer literate (proficiency with MS office specifically)
