Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post : Sr. Associate/Associate-Regulatory Affairs
Job Responsibilities
• 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
Candidate Profile
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)
Other Information:
Experience: 5 to 8 year
Location: Maharashtra - Mumbai
Education: M.Pharm, M.Sc, B.Pharm
Industry Type: Pharma/biotech/Clinical research
Functional Area: Regulatory Affairs
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