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.
*Accountable 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