Parexel Regulatory Affairs Associate Job Openings Bangalore
About the Company
Welcome to Parexel, a leading consulting firm playing a pivotal role in assisting biopharmaceutical and medical device companies in navigating the intricate regulatory landscape. With a commitment to collaboration, innovation, and continuous learning, Parexel is dedicated to bringing products to market faster and ensuring their sustained success.
Company Vacancies List
Regulatory Affairs Associate
Additional Locations: Hyderabad, Telangana, India
About the Role
As a Regulatory Affairs Associate at Parexel, you will contribute significantly to the success of biopharmaceutical and medical device companies by navigating the complex regulatory landscape. Leveraging your scientific, technical, and regulatory expertise, you will collaborate closely with clients to develop and implement regulatory strategies, facilitating the expedited market entry and longevity of their products.
- 2 to 5 years of experience in Regulatory Affairs-CMC
- Willingness to work in EU Shifts
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory input on procedural and CMC documentation requirements.
- Liaise closely with cross-functional members with aligned product responsibilities.
- Develop, execute, and maintain submission delivery plans and content plans.
- Author dossier sections based on changes to approved MAA.
- Manage lifecycle activities in the EU markets (preferable).
- Knowledge of CTD guidelines.
About the Department & Responsibilities
- Understand regulatory frameworks and regional trends
- Provide regulatory input on procedural and CMC documentation
- Collaborate with cross-functional teams
- Develop, execute, and maintain submission delivery plans
- Author dossier sections based on changes to approved MAA
- Manage lifecycle activities in the EU markets
- Knowledge of CTD guidelines
To apply for this job please visit jobs.parexel.com.