Regulatory Expert for Complex Regulatory Submissions
3 days ago
Job Overview:
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We are seeking an experienced Senior Regulatory Consultant with EU market experience to join our team. The ideal candidate will have a strong background in CMC authoring and reviewing, specifically Module 3, and excellent interpersonal/communication skills.
The successful candidate will contribute to the preparation of regulatory submissions, including IND, PMA, NDA, MAA, and CTD, and work closely with multidisciplinary project teams to develop products throughout their life cycle.
Key Responsibilities:
- Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
- Prepare administrative and technical components of regulatory agency submissions, including electronic submissions.
- Manage day-to-day regulatory activities for assigned projects according to agreed timelines, scope of contract, budgets, and strategies.
- Participate as a subject matter expert in multidisciplinary project teams and help team members with day-to-day troubleshooting activities.
Qualifications:
- Minimum 5 years of experience in CMC authoring and reviewing (specifically Module 3).
- Must have EU market experience.
- BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
- Demonstrated experience in contributing to the preparation of regulatory submissions.
- Excellent interpersonal/communication skills, including excellent written and verbal communication skills.
About Syneos Health:
We have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
Additional Information:
Tasks, duties, and responsibilities may be modified at any time. Equivalent experience, skills, and/or education will also be considered. We are committed to compliance with all applicable laws and regulations.
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