James Prasad

James Prasad Email and Phone Number

Regulatory Affairs Senior Manager @ Nova Pharmaceuticals Australasia Pty Ltd
James Prasad's Location
Stanhope Gardens, New South Wales, Australia, Australia
James Prasad's Contact Details

James Prasad personal email

About James Prasad

Started my career in the pharmaceutical industry working as a R&D analyst/Validation analyst at the Douglas Pharmaceuticals. Following this I worked as an evaluator at Medsafe for 5 years with 3 and a half years in OTC evaluation and 1 and a half years in prescription medicine evaluation.In Australia I have worked as a regulatory consultant at Regulatory Concepts Pty Ltd, regulatory affairs associate at sanofi-aventis australia pty ltd (contractor) and senior regulatory affairs associate at Phebra Pty Ltd, MSD Australia and Galderma Australia. I was promoted to the position of the Regulatory Affairs Manager at Galderma Australia at the end of 2017. I joined A. Menarini Australia Pty Ltd in July 2018 where I have worked as a Regulatory Affairs and Quality Assurance Manager responsible for both regulatory affairs and quality assurance teams. Following my redundancy at Menarini in 2020 I have worked as a Regulatory Affairs Manager at QBiotics Group. I am currently working as a Senior Regulatory Affairs Manager at Nova Pharmaceuticals Australasia Pty Ltd. Over the years I have worked on the registration and regulation of prescription, OTC, medical devices, sunscreens and cosmetics and have working expertise in all these areas. However, my particular strength is prescription regulatory affairs. My goal is to continue building on my regulatory affairs knowledge while contributing to the success of my employer and collegues.Specialties: Compliation, submission and maintainance of prescription and OTC dossier registrations in Australia and New Zealand.Listing of sunscreens and complementary medicines on the ARTG. Registration, conformity assessment renewals and variations of Class III medical devices in Australia.Regulation of cosmetics in Australia and New Zealand. Generating regulatory submission from scratch.Liasing with the varies committees and regulators as necessary.Problem solving.Critical assessment and evaluation of submissions.Project management of regulatory submissionsCoaching and development of direct reports and people managementRegulatory strategy and negotiationRegulatory complianceLine management

James Prasad's Current Company Details
Nova Pharmaceuticals Australasia Pty Ltd

Nova Pharmaceuticals Australasia Pty Ltd

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Regulatory Affairs Senior Manager
James Prasad Work Experience Details
  • Nova Pharmaceuticals Australasia Pty Ltd
    Senior Regulatory Affairs Manager
    Nova Pharmaceuticals Australasia Pty Ltd May 2023 - Present
    Bella Vista, New South Wales, Au
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  • Nova Pharmaceuticals Australasia Pty Ltd
    Regulatory Affairs Manager
    Nova Pharmaceuticals Australasia Pty Ltd Aug 2022 - May 2023
    Bella Vista, New South Wales, Au
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  • Qbiotics Group Limited
    Regulatory Affairs Manager
    Qbiotics Group Limited May 2021 - Aug 2022
    Taringa, Queensland, Au
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  • Boehringer Ingelheim
    Regulatory Affairs
    Boehringer Ingelheim Feb 2021 - May 2021
    Ingelheim Am Rhein, Rhineland-Palatinate, De
    Develop submission strategy, compile and submit Cat.1 (line extensions and Type F, J, H) and minor variation applications to the TGA and Medsafe within the planned affiliate timelinesObtain GMP clearances for my assigned products as required.Coach and review the work of regulatory associates
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  • Menarini Group
    Regulatory Affairs And Quality Assurance Manager
    Menarini Group Jul 2018 - Sep 2020
    Firenze, Italy, It
    • Guided the regulatory affairs and quality assurance department to obtain successful registration of both new and existing products and be compliant and effective with all quality assurance activities. • Provided leadership for successful execution of regulatory strategies and business plans. • Managed and developed my team of professionals through mentoring and coaching to improve productivity and outputs. • Created and maintained the annual regulatory and quality project plans, providing up to date project status reports including budgeting for regulatory and quality projects, as well as developing and resourcing the regulatory the 5 year plan. • Developed regulatory affairs submission strategy and undertook regulatory submissions including Category 1 applications and minor variation submissions to reduce post-approval commitments and submission backlog. • Key departmental contact for the internal and external stakeholders including the TGA and Medsafe.• Identified gaps, justified and increased department resources with senior management.• Facilitated the affiliates, often aggressive, product submission and launch plans through collaboration with the cross-functional teams, solving complex problems by taking new perspective to using existing solutions, allocating resources and effective project planning. • Ensured growth and maintenance of Menarini’s valued and respected brands.
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  • Galderma
    Regulatory Affairs Manager
    Galderma Jan 2018 - Jul 2018
    Zug, Ch
    Develop and provide regulatory strategies related to the submissions in Australia and New Zealand to the responsible business units, the Galderma leadership team and the corporate regulatory colleagues. Prioritize, prepare and submit new product registrations, variations and post approval reporting obligations for the Galderma prescription, consumer and medical devices products in Australia and New Zealand to meet the company’s business objectives and timelines. Act as the affiliate regulatory point of contact. Mentor, coach, train and guide regulatory & quality colleagues, establishing and communicating performance goals, objectives and standards, appraising performance and recommending compensation actions.Manage day to day running of the regulatory department.Interact and negotiate with the internal and external (TGA and Medsafe) stakeholders to resolve review questions and related issues and obtain the best regulatory outcome for Galderma.Ensure compliance of regulatory activities in ANZ are consistent with federal and state laws and Galderma internal procedures.Develop and manage effective working relationships with the TGA, other state and federal authorities and Galderma global and cross-functional teams.Monitor changes to the regulatory landscape in Australia and New Zealand and align resources and activities to accordingly to ensure that the company is well equipped to deal with these changes
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  • Galderma
    Senior Regulatory Affairs Associate
    Galderma May 2015 - Dec 2017
    Zug, Ch
    Australian affiliate regulatory lead for all regulatory activities across the company’s prescription, over-the-counter, cosmetics and Aesthetic &Corrective (devices) business units.Strategize, prioritize, prepare and submit new product registrations and major variations for registered products (prescription, OTC and devices) to TGA and Medsafe to meet Galderma Australia business objectives and timelines.Recruit, train, mentor and develop staff, establishing and communicating performance goals, objectives and standards, appraising performance and recommending compensation actions.Perform regulatory maintenance of registered products.Manage in-house regulatory files, documentation and databases.Obtain and maintain GMP, state and federal licences and import permits where required.Coordinate local product recalls.Develop and manage effective working relationships with the TGA, other state and federal authorities, Galderma Global and other cross-functional teams.
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  • Msd Australia & New Zealand
    Senior Regulatory Affairs Associate
    Msd Australia & New Zealand Jan 2013 - May 2015
    Macquarie Park, Nsw, Au
    NCE, new presentation and new indication Cat.1 compliation/submission and approval activities.Compliation and Cat.1 submission of clone applications.Compilation and approval of minor variations including Cat.3, SARs, SRRs, s9D(1)s, s14 applications, CPPs etc.Managing submission and approval of GMP clearances.Managing the generation, submission and approval of artwork and leaflets for regulatory submissions.Mentoring of junior staff and contractors.Participating in the product life cycle management and contributing to generic defence activities.Project management of all aspects of regulatory submissions.Devicing submission strategies and liasing with cross-functional teams within MSD to implement these strategies.Support business strategies through preparing specific regulatory submissions.Coordinating company responses to TGA consultation documents.Problem solving and managing expectations.Provide resolution to regulatory problems and seek opportunities for improvement.Preparing and presenting project updates and briefings to the core product teams and management as required.Supporting overseas requests related to my submissions.Negotiations with quality, artwork centers and third party contractors and product supplier regarding regulatory issues.Attention to detail.Time management.Risk assessment.
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  • Phebra Pty Ltd
    Senior Regulatory Affairs Associate
    Phebra Pty Ltd Nov 2009 - Dec 2012
    Lane Cove West, New South Wales, Au
    Registrations on prescription medicines in Australia and New Zealand including compliing and submitting Cat.1, Cat.3, SAN, MEC etc.Regulatory project manager for Phebra manufacturing site change.Staff mentoring and coordination of specialist projects.
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  • Sanofi-Aventis
    Regulatory Affairs Associate
    Sanofi-Aventis Oct 2008 - Oct 2009
    Paris, France, Fr
    Cat.1, Cat.3, SAN registrations on prescription & OTC medicines in Australia and New Zealand.
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  • Regulatory Concepts Pty Ltd
    Principal Consultant - Prescription & Otc Medicines
    Regulatory Concepts Pty Ltd Oct 2007 - Oct 2008
    Cat.1, Cat.3, SAN, CPP, SRN etc registrations on prescription & OTC medicines in Australia and New Zealand. Project management.Client management.
  • New Zealand Medicines And Medical Devices Authority
    Advisor Science (Evaluation)
    New Zealand Medicines And Medical Devices Authority Jun 2003 - Oct 2007
    Evaluator of the OTC and prescription medicuine dossiers for compliance with the New Zealand Medices Act and regulations, Medsafe guidelines, ICH and international pharmacopieas.
  • Douglas Pharmaceuticals Ltd
    Research Analyst
    Douglas Pharmaceuticals Ltd Jan 2002 - Jun 2003
    Auckland, Auk, Nz
    • Method development on both oral and tablet samples for small scale manufacture (laboratory batches).• Testing of active and raw materials.• Testing of innovator products & trial batches at various conditions including the stress and degradation studies (assay, related substances, dissolution, uniformity of content/ dose/mass)• Formulation development work from small-scale laboratory trial batch to larger scale commercial trial batch manufacturing.• Write raw material and finished product Analytical Procedures with reference to Ph. Eur. and USP.• Write method validation protocols for assay & related substances.• Set specifications for raw material, excipient and finished products.
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James Prasad Skills

Regulatory Submissions Regulatory Affairs Pharmaceutical Industry Gmp Cmc Regulatory Affairs Validation Ectd Project Management Anda Sop Quality Control Negotiation Leadership Change Control Generic Programming Strategy Regulatory Requirements Problem Solving Teamwork Pharmaceuticals Regulatory Strategy Time Management Creating Reports And Briefings Dossier Evaluation Peer Mentoring Multitasking Skills Close Attention To Detail Self Starter Compliance Communication Skills People Management Regulatory Compliance Regulatory Strategy Development Regulatory Analysis Regulatory Documentation Regulatory Filings Regulatory Guidelines Regulatory Management Team Leadership Strategic Leadership Cross Functional Team Leadership Performance Management People Development Medical Devices Pharmaceutics Prescription Drugs Over The Counter Medicine

James Prasad Education Details

  • The University Of British Columbia
    The University Of British Columbia
    Organic Chemistry
  • The University Of The South Pacific
    The University Of The South Pacific
    Organic Chemistry
  • The University Of The South Pacific
    The University Of The South Pacific
    Organic Chemistry
  • The University Of The South Pacific
    The University Of The South Pacific
    Chemistry And Biology

Frequently Asked Questions about James Prasad

What company does James Prasad work for?

James Prasad works for Nova Pharmaceuticals Australasia Pty Ltd

What is James Prasad's role at the current company?

James Prasad's current role is Regulatory Affairs Senior Manager.

What is James Prasad's email address?

James Prasad's email address is ja****@****ail.com

What schools did James Prasad attend?

James Prasad attended The University Of British Columbia, The University Of The South Pacific, The University Of The South Pacific, The University Of The South Pacific.

What skills is James Prasad known for?

James Prasad has skills like Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Gmp, Cmc Regulatory Affairs, Validation, Ectd, Project Management, Anda, Sop, Quality Control, Negotiation.

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