Senior Regulatory Affairs Consultant- CMC Biologics
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Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Senior Regulatory Affairs Consultant- CMC Biologics
- Extensive experience in managing new registrations life cycle maintenance and renewals for biological products including vaccines recombinant proteins monoclonal antibodies and plasmaderived therapies across major markets such as the US EU Japan Canada Switzerland and Australia.
- Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
- Preparation and review of Marketing Authorization Applications & Variations for filing in US EU Japan Canada Switzerland Australia.
- 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.
- Strong communication and collaboration skills ability to work independently.
- The role is for a team lead with expectations to guide/mentor team members on technical aspects including regulatory filings to global markets
Experience level: 10 to 14 years of relevant experience
Location: India Remote
Education:
Minimum of a bachelors degree in a Scientific or Technical Discipline Advanced Degree preferred
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
