Regulatory Operations Associate Jobs in Bangalore - Novotech

Regulatory Operations Associate - anywhere in India

About Novotech

Novotech is internationally recognised as the leading independent and full service contract research organisation (CRO) in the Asia Pacific region. We provide a wide range clinical development services across all research phases and therapeutic areas; and have been instrumental in the success of hundreds of Phase I – IV clinical trials throughout the Asia Pacific. Powered by the highest quality people, Novotech strives to set the benchmark for both business and clinical trial performance.

Our people are one of our key strengths. We value our people and recognise the work they do. We are lucky to have the best people and talent from across the Asia Pacific region work together to deliver to clinical trial success for our clients. Our people and those we look to recruit have an attitude of making things happen. They are problem solvers, driven with a focus on delivering quality, accountability and a high level of performance.

About The Position

The objectives of this position are to plan, prepare, review and submit high quality Ethics Committee (IRB/IEC) and Health Authority applications to ensure timely clinical trial approval and start up for Novotech’s clients.

The position is based in our Bangalore office, reporting to the Regulatory Operations Associate based in India . As a member of our Regulatory Operations team you will be supporting submissions for project teams in primarily in Australia and New Zealand, but also across the Asia region.

Required Qualification(s)

You should be a graduate in a clinical, pharmacy or life sciences related field with at least 2 years clinical research experience gained in a pharmaceutical company or CRO. Involvement in or exposure to preparation of Ethics Committee or Health Authority Applications in any country would be required. Involvement in study start up or in-house data review / monitoring and/or CRA experience would be advantageous. Training on Novotech processes and local country requirements would be available to ensure your success.

Ensuring ICH GCP and Regulatory compliance is fundamental to the conduct of clinical research.

Core Responsibilities

• Preparation, review and provision of ethics committee applications for clinical trials, based on the protocol, Investigator brochure and available information, to ensure timely approval of clinical trials.
• Reviewing questions or comments raised by ethics committees, seeking further information and discussing these with the project team and/or client to formulate an appropriate response.
• P reparation, review and provision/submission of applications to Health Authorities to ensure timely approval of clinical trials.
• Reviewing questions or comments raised by ethics committees, seeking further information and discussing these with the project team and/or client to formulate an appropriate response.
• Review and approval of proposed packaging and labelling for clinical trial material to ensure compliance with local regulations.
• Preparation, review and submission of importation and/or exportation licences and/or permits for clinical trial materials, in accordance with local requirements.
• Preparation and/or customisation and review of Patient Information Sheet / Consent form in accordance with ICH GCP and local requirements.
• Preparation, review and approval of periodic reports to ethics committee’s and Health Authorities.
• Review, comment and approval of Activation packages for release of Investigational Product.
• Register the clinical trial on clinical trial registries, in accordance with local regulatory requirements.
• More experienced Associates may be assigned as a project regulatory lead for multi-region projects, taking responsibility to coordinate regulatory activities with colleagues in Asia.