B.Pharm Candidates Apply for Associate Regulatory Affairs @ Apotex Research

Apotex Research Pvt. Ltd.
Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 10,000 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies has over 6,000 employees. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe.

Job Title :  Sr.associate Regulatory Affairs

No. of Posts :   2

Job Description: Responsible for compilation and submission of dossiers for registration of Apotex products in identified markets. Also responsible for providing support and regulatory guidance to a team of RA Associates in the completion of projects supporting regulatory submissions.

*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.

for assessing, coordinating and compiling deficiency responses in a timely manner.
*Works with other functional areas to resolve issues related to information for regulatory submissions.
*Prepare and peer review labelling, product monographs and marketing materials.
*Evaluate, prepare and peer review of post approval supplements to manage the regulatory product life cycle as applicable.
*Review of change control documents.
*Approval of change control documents and quality notifications as assigned.
*Assist in product launch activities as required.
*Maintains regulatory databases to ensure accuracy of information.
*Perform additional duties as assigned by RA Manager.
*Works as a member of a team to achieve all outcomes
*Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence
*Performs all work in accordance with all established regulatory and compliance and safety requirements
*Relationship with Internal/External Customers & 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 and suppliers to request and/or provide data relevant to submissions.
*Contribute to the creation and promotion of an environment of teamwork and empowerment.


*B. Pharm degree or equivalent in Pharmacy or Life Sciences. Diploma from a
RA program would be an asset.
*Minimum 3-5 years pharmaceutical experience in an RA role.
*Good oral / written communication, organizational and interpersonal skills.
*Attention to detail.
*Demonstrates leadership skills
*Computer literate. (Proficiency with MS Office specifically)

*Minimum 3 Years (three) years industry experience of which at least 2 years should be in regulated markets like US / EU / AUS or CDN.
*should have hands on experience with regulatory dossier submission in US, EU, AUS, CDN and other Emerging markets, Managing product life cycle management (PLCM), Deficiency response management, deviation filings Etc…
*Computer literate with good oral & written communication skills
*Knowledge and exposure to GMP, GCP, GLP and ICH guidelines

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