Regulatory Affairs Associate Job at PAREXEL | M.Pharm, M.Sc or B.Pharm apply

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Regulatory Affairs Associate

Job Description
Relevant 2 or years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
• To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
- Submission delivery strategy
- Review of documents
- Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• 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.
• Authoring the dossier sections based on the changes to approved MA. Knowledge of change evaluation according to country guidelines Experience in managing lifecycle activities in the EU markets.
• Knowledge of CTD guidelines

Candidate Profile
Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences

Additional Information
Experience : 2 years
Qualification : B.Pharm or M.Pharm, M.Sc
Location : Karnataka - Bengaluru
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th October, 2022