CANADA REGULATORY AFFAIRS – MANAGER
Responsible for providing strategic and hands on operational support to all regulatory activities related to the Canadian Business to ensure regulatory approvals, launch and compliance for new and marketed product
- Preparation, review and submission of various types of regulatory filings to Health Canada (ANDS / NDS related filings for generic drugs in dosage forms like solid orals, injectable, patches etc.)
- Need based interactions with Health Canada, offsite teams (internal) and contract manufacturers.
- Provide strategic regulatory support / guidance during selection / development phase of a drug product and dossier review
- Assist in reviewing of all pre-filing, pre-approval and post approval submissions from internal teams in accordance with current regulations from Health Canada. This review includes a detailed scientific/regulatory review ensuring compliance to all appropriate regulations and communicating significant and/or potential issues to regulatory team leader / management.
- Independently manage Drug Establishment License (DEL) on behalf of Canadian importing entity including submissions of GMP packages, annual registrations / renewals before NERBY and tracking.
- Review and approval of labeling artworks, change controls, promotional materials etc. for the Canadian products.
- Provide regulatory support to day-to-day operations in Canada and provide support to QA, PV, IP, legal contract manufacturing operations, and business group on data requests / queries.
- Updating and maintenance of regulatory documentation and databases.
- Assist the regulatory team members in electronic publishing and submissions.
- Create and maintain a regulatory document control with appropriate distribution of regulatory documents.
- Review of internal documents for compliance to Regulatory commitments
- Any additional responsibilities as assigned by hiring manager.
- Need based support to US FDA related regulatory submissions, reviews and internal customer support.
Experience / Skills
- BS/MSdegree in Pharmacy/ Scientific discipline with at least 8 -10 years of generic pharmaceutical industry experience.
- Good understanding of Pharmaceutical development, manufacturing processes, clinical, non-clinical knowledge, c GMP and labeling.
- Understanding of the workings of the pharmaceutical regulatory and manufacturing environment
- Thorough understanding of regulations and guidance published by US FDA & Health Canada.
- Strong oral and written communication skills
- Strong organizational skills, attention to detail and flexible.
- Proven ability to anticipate challenges and negotiate through them to achieve desired outcome.
- Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously with minimal supervision.
- Prior experience of interaction with Regulatory agencies highly desired.