Senior Analyst/Executive-Labelling

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

Job Summary

Perform for all the labelling update and maintenance activities with respect to New Product Development Label creation and Product Life Cycle maintenance update for products in Canada Market. Interact with compilers for product allocated to understand any data related queries or data availability issues. Taking followups about the assigned projects from compilers. Co-ordinate with the vendor/affiliates to ensure the timely creation and update of the artwork. Interact on a peer level with ARPL colleagues and Canada affiliates for addressing Health Authorities requirement or queries.Maintain all the trackers for label to ensure the timely submission of the labels to health authority.

Job Responsibilities

• Responsible for coordination & preparation of regulatory submissions and
• Prepare and submit all the supporting documents for labelling submissions as per the type of submission for Canada
• Co-ordinate with POC/ Vendor for Artwork creation and
• Maintain all the tracking requirements for Label update (RIMS, Tracking sheets, CCR, )
• Prepare and update the label/ Monograph as per the requirement in New Drug development or Product lifecycle maintenance in US and Canada
• Develop & maintain regulatory knowledge of Canada
• Manage the final product submissions and negotiate and communicate effectively with regional team/regulatory authorities to obtain timely product
• Perform ESG submissions and maintain the
• Author the responses and be a decision maker for the changes applicability in the labels
• Review all the assigned tasks and ensure PM and form checklists is filled by both compiler and reviewer to maintain quality of submissons is
• Define the priority of the labelling requirements and plan the submission based on priority.
• Maintains user-level knowledge of labelling software's
• Interacts with other internal departments when
• Shows initiative to remain current on new labelling regulations and international guidelines and seeks guidance from Leader and management to enhance
• Performs all work in accordance with all established regulatory and compliance and safety
• Works in a safe manner collaborating as a team member to achieve all
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR
• All other relevant duties as
• Train the new joinees on LAMS software and process related

Job Requirements

Education

o M Pharmacy, B Pharmacy or Equivalent Degree

Knowledge, Skills and Abilities

o Compilation of dossier submissions via eCTD docubridge.

o Animal assays using dosing method, blood withdrawal techniques, oral dosing techniques etc.

o Molecular biology techniques: Gel electrophoresis, Plasmid and genomic DNA extraction, Transformation, Cloning and PCR.

o Computer Proficiency:

MS Excel, powerpoint proficient

Sound knowledge of MS Office, Internet, email tools.

o An effective communicator with good presentation skills and organizational abilities.

Experience:

o 1 to 5 years in Regulatory Affairs