Trainee, Regulatory Affairs Plcm

0-1 years

Not Disclosed

Mumbai

10 June 14, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.

Job Summary

Collation, compilation and dispatch/submission of regulatory documentation for assigned projects.

Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures.

Supporting and/or coordinating regulatory affairs projects (especially tender projects), as assigned.

Job Responsibilities

Collation, compilation and timely dispatch of required regulatory documentation to Apotex affiliates/customer and follow-up on timely submission of applications to the health authority.
Timely communication and follow up with the respective departments for compilation of tender submissions and for database updates
Responsible to respond to queries received from Apotex affiliates/customer and health regulatory agencies on regulatory submissions.
Maintain records in global regulatory databases, update established trackers & status sheets and ensure accuracy of information.
Adherence to the responsibilities as assigned, act as a back-up for team members and support other projects as & when assigned.
Completion of all the assigned trainings in timely manner.
Contributes towards the creation and promotion of an environment of teamwork and empowerment built on mutual trust and respect.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
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 policies.
All other relevant duties as assigned.

Job Requirements

Education:
- A Graduate/ Post graduate in Pharmacy.
Knowledge, Skills and Abilities:
- Candidate should have good academic background. Knowledge about New Product Dossier and PLCM submission requirements will be an additional advantage.
Experience:
- Should have 0-1 years of regulatory affairs experience in International markets.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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