OverviewEli Lilly Regulatory Affairs Associate Full Time in Guelph, ON
Branch Guelph ON CA
Regulatory Affairs Associate
Aptitude for critical thinking and problem solving. The Regulatory Affairs Associate is responsible for completion of Chemistry and Manufacturing Submissions,…
The Regulatory Affairs Associate is responsible for completion of Chemistry and Manufacturing Submissions, Post NOC compliance and providing expert advice and assistance. This position is a member of the Global CMC Regulatory group and would be responsible for maintenance of one or more products from a global perspective. The Regulatory Affairs Associate is responsible for all duties as described below, while providing a leadership function to the Associate level and assisting more in the creation, facilitation, monitoring and ownership of Regulatory Submissions.
- Support post NOC product regulatory compliance including manufacturing changes, notifiable changes and labeling changes
- Effectively lead, direct and coordinate resources to execute high quality approvable regulatory submissions (Chemistry & Manufacturing).
- Interact effectively with Canadian regulatory agencies to negotiate the necessary requirements for approvals.
- participate in and support product development and advise other departments on regulatory issues and strategies
- source data from various key contributors
- develop project timelines
- ensure submission content meets regulatory requirements
- write submission summaries
- compile and file submissions
- build and maintain external contacts (VDD) as well as internal contacts.
- responds to requests for additional information pertaining to submissions under review as required
- uses network of contacts to gather information [e.g. clarify interpretation of regulations and/or guidelines]
- develops appropriate strategy to resolve registration issues
- effectively facilitates the negotiation of product labels
- Post NOC Compliance, including
- Regulatory changes/updates for products
- Labelling changes
- Establishment Licenses
- Annual notifications
- Notifiable changes
- understands the impact of new or revised regulations, guidelines, or policies
- interprets and applies regulations to marketed products
- understands the relevance of GCP and GMP requirements to Regulatory Affairs
- able to critically assess and provide feedback on new or revised regulations, guidelines and or policies
- Support daily manufacturing operations by reviewing global regulatory impact of deviations, change controls, and other manufacturing driven initiatives
- Provide data and documentation to affiliates in support of product registration and renewal activities
- Network with manufacturing, quality, MS&T, and other manufacturing support groups to ensure continuity of product supply
B.Sc. or M.Sc. in chemistry, biochemistry, microbiology, pharmacy or closely related discipline.
- Must have a minimum of 3 years (MSc) or 5 years (BSc) of full time pharmaceutical/ veterinary regulatory experience in a similar position.
- Thorough knowledge of the Food and Drugs Act, Food and Drug Regulations, GMP Regulations.
- Thorough knowledge of Pharmaceutical Compendia and a deep understanding of pharmaceutical chemical methodology and analytical procedures.
- Works independently in a self-managed environment.
- Able to interpret data and information from a variety of sources drawing appropriate conclusions based on a thorough understanding of good scientific practice, Good Manufacturing Practice requirements and company policies and procedures.
- Investigates and/or assists others in the investigation of issues with the potential to impact product quality and/or compliance to GMP requirements.
- Suggests and implements solutions balancing good science, product quality impact, and GMP compliance, cost and business needs.
- Accepts responsibility for self and team.
- Ability to work under pressure and make rapid and accurate decisions.
- Challenges existing methods and processes in an effort to find areas for improvement.
- Drives the implementation of new methods and processes.
- Organizational, leadership and project management Skills.
- Strong interpersonal skills.
- Facilitating and coaching skills.
- Able to balance a variety of tasks with the appropriate priority.
- Well-developed written and verbal communication skills.
- Aptitude for critical thinking and problem solving.
Elanco Canada will conduct, at its own expense, background search (including verification of educational credentials, contacting three of your personal references) of the successful candidate.
Elanco Canada is committed to employment equity. We encourage applications from qualified women, members of visible minorities, Aboriginal peoples, and persons with disabilities.
Please do not contact us via phone. We appreciate all who apply; however, only those candidates selected for an interview will be contacted.
Candidates must be legally eligible to work in Canada. Elanco Canada does not sponsor work permits or other employment visas.
Employment Type: Full Time
Location: Guelph, ON, CA
Posted on: 2015-09-23