15h Left Trainee, Regulatory Affairs PLCM

3 weeks ago

Mumbai, Maharashtra, India Thepharmadaily Full time
Job Description

- 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.

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

  • Regulatory Affairs Professional

    7 days ago

    Mumbai, Maharashtra, India beBeeSpecialist Full time US$ 40,000 - US$ 80,000

    Regulatory Affairs SpecialistThe role involves the compilation, submission and management of regulatory documentation for assigned projects.Responsibilities include maintaining accurate database records pertaining to products, in line with established systems and processes.Supporting and coordinating regulatory affairs projects, as assigned, including tender...

  • Trainee, GBS GRA PLCM-GBS-PLC-GBS-PLCM G

    5 days ago

    Mumbai, Maharashtra, India Apotex Full time US$ 80,000 - US$ 1,20,000 per year

    ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat...

  • Urgent: Trainee, GBS GRA PLCM-GBS-PLC-GBS-PLCM G

    3 weeks ago

    Mumbai, Maharashtra, India Apotex Inc. Full time

    Job DescriptionApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines...

  • Lead Exec, GRA PLCM

    4 weeks ago

    Mumbai, Maharashtra, India Apotex Inc. Full time

    Job DescriptionAbout 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...

  • Regulatory Affairs Specialist

    2 days ago

    Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000

    Regulatory Affairs Manager Job DescriptionThe role involves developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management: Preparation, review and submission of regulatory documentation (e.g., dossiers,...

  • Manager- Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Piramal Enterprises Full time

    Job DescriptionJob Description :Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities,...

  • Regulatory Affairs Professional

    5 days ago

    Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 2,20,00,000 - ₹ 2,54,00,000

    Regulatory Affairs LeaderSr Manager Regulatory Affairs responsible for developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance, and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management:Preparing, reviewing, and submitting regulatory documentation to...

  • Regulatory Affairs Specialist

    2 days ago

    Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000

    Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will...

  • AGM Regulatory Affairs

    4 weeks ago

    Mumbai, Maharashtra, India NMS Consultant Full time

    Job DescriptionAGM position -Regulatory AffairsB.Pharm / M.Pharm / M.Sc 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage formsKey Responsibilities:- Ensure timely submission of ANDAs, supplements and amendments- Review of registration dossiers, amendments, supplements and annual reports prepared by subordinates for...

  • Regulatory Affairs Specialist

    14 minutes ago

    Mumbai, Maharashtra, India Tek Support Full time

    Job DescriptionJob Title: Regulatory Affairs Specialist Med/Pharma (Female)Location: RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities,...