Regulatory CMC Project Manager
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Job Location:
Raleigh, WV - USA
Monthly Salary:
Not Disclosed
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.
If you are passionate about regulatory affairs and project management and are looking for a challenging and rewarding opportunity we would love to hear from you!
Join our dynamic team at Parexel where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing dedicated client partnership and play a pivotal role in their regulatory affairs department.
Key Responsibilities:
Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines identifying ownership and tracking deliverables from authorship initiation through to approval ensuring timely and high-quality submissions.
Strategic Planning: Under the guidance of the Regulatory CMC Lead develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program ensuring alignment with global regulatory requirements.
Project Management: Serve as the project manager for meetings adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed.
Regulatory Support: Assist in the preparation of materials for health authority engagements ensuring that all documentation is thorough accurate and compliant with regulatory standards.
Health Authority Engagement: Support the preparation of materials for health authority engagements
Qualifications:
Bachelors degree in a relevant field (e.g. Life Sciences Regulatory Affairs Project Management).
3 years proven experience in regulatory affairs particularly in CMC (Chemistry Manufacturing and Controls).
Strong project management skills with a track record of managing complex projects and meeting deadlines.
Excellent organizational and communication skills.
Excellent time management abilities
Proficient in Microsoft Office Suite
Proven experience with project management software ie. Smartsheet
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced dynamic environment.
Additional Requirements:
Must be able to work East Coast hours regardless of physical location in Central or West Coast US time zones
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status which in the US includes race color religion sex sexual orientation gender identity national origin disability or protected veteran status.
Required Experience:
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
