Apotex Inc Recruitment November 2020.Apotex Inc Notification full detailes below.Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world.
Important Vacancy details:
- Post Name: Associate- Regulatory Affairs, GCC/MENA
- Education:A post graduate/ graduate degree or equivalent in Life Sciences / Pharmacy from a recognized school Minimum 5-8 years of experience in RA role
- Experienced:5-8 years of experience
- Location:Mumbai, MH, IN, 400083
- Salary: NA
- Openings: NA
Job Description: Hiring For Associate- Regulatory Affairs, GCC/MENA in Apotex Inc!
- 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
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online