B Pharmacy & M Pharmacy Job Vacancy @ Parexel – Regulatory Affairs
Parexel hiring candidates having bachelor’s and master’s degree in pharmacy. B Pharmacy job, M Pharmacy job vacancy 2022. Pharmacy job opening 2022. Regulatory affairs associate job opening 2022. Pharma associate job opening 2022. Regulatory associate job opening 2022. Associate job vacancy, Check out all the details on the same below:
Job Title: REGULATORY AFFAIRS ASSOCIATE
Location: BENGALURU, KARNATAKA, INDIA
Job ID 82196BR
Eligibility Criteria: Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences
Skiils & Responsibilties:Â
- Good understanding of the 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 and 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.
Apply Online
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