REGULATORY AFFAIRS JOBS FOR B. PHARM / M. PHARM ANY LIFE SCIENCE CANDIDATES AT PAREXEL.

PAREXEL JOB OPENINGS FOR REGULATORY AFFAIRS FOR B. PHARM / M. PHARM ANY LIFE SCIENCE CANDIDATES.

ABOUT PAREXEL:

As one of the world's leading global clinical research organizations (CRO), we provide the clinical development capabilities and integrated consulting expertise it takes to streamline development every step of the way — faster and more cost-effectively. From decentralized clinical trials to regulatory consulting services and leveraging real-world insights, our therapeutic, technical, and functional ability is underpinned by a patient-first culture embedded in our DNA. Our over 18,000 employees have a deep conviction in what we do, and together with our customers, we are shaping the next generation of therapies, one patient at a time. 

JOB DETAILS:

DEPARTMENTS: Regulatory Affairs

POSITION: Regulatory Affairs Associate

QUALIFICATION: Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences.

JOB LOCATION: India - Karnataka - Bengaluru

JOB DESCRIPTION:

Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries . 

Experience with ROW countries would be a plus.

Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.

Liaise closely with cross-functional members with aligned product responsibilities.
Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.

To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable)

Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents

Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.

HOW TO APPLY: Interested and eligible candidates can apply online through given below link.

APPLY ONLINE>>>>

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