(Senior) Regulatory Affairs Consultant CMC small molecules
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Job Location:
Monthly Salary:
Posted on:
14 hours ago
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.
Are you passionate about regulatory affairs in the life science industry Do you thrive in a dynamic team environment and enjoy managing complex projects Parexel is seeking a talented (Senior) Regulatory Affairs Consultant with CMC writing background (small molecule) to join our growing team!
As a (Senior) Regulatory Affairs Consultant CMC at Parexel you will be at the forefront of managing and coordinating regulatory submissions across various markets. This role offers an excellent opportunity to develop your expertise in regulatory affairs while working with a diverse range of clients and stakeholders.
The role can be office or home based.
Role Responsibilities:
- Manage lifecycle maintenance activities including renewals variations and responses to deficiency letters
- Coordinate submission and management work in Veeva Vault
- Collaborate with various stakeholders attending regular calls and meetings
- May serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
- Ensure project team delivers high-quality work meeting client expectations and timelines
- Manage project financials and identify new business opportunities
- Deliver consulting services within your area of expertise
- Maintain professional interactions with clients and internal teams
Skills and experience required for the role:
- University degree in a life science discipline
- Solid regulatory experience in EU other non-EU markets preferred
- Proficiency in Module 1 and 3 writing
- Strong organizational and prioritization skills
- Excellent communication and teamwork abilities
- Ability to work independently and under guidance of Project Leads or Technical SMEs
- Commitment to continuous learning and self-development
- Fluent in English written and spoken
Required Experience:
Contract
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
