Sr Regulatory Consultant
Full time @Syneos Health Clinical posted 8 months ago in Pharma Shortlist Email JobJob Detail
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Job ID 7326
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Career Level Executive
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Experience 2 Years
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Gender MaleFemale
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Category / Function Management
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Qualifications Degree Bachelor
Job Description
Description
Sr Regulatory Consultant
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job responsibilities
- Responsible for day-to-day contribution to project teams and projects.
- Acts as a representative of the GRAS regulatory department with other departments.
- Contributes technical expertise to proposals and assists with Business Development initiatives.
- Understands project budgets, scope of projects, allocated hours, and tracks compliance.
- Interacts with internal and external personnel, clients, and technical experts on projects.
- Conducts regulatory research on projects as needed.
- Provides operational advice to clients.
- Prepares consulting reports under guidance.
- Arranges, leads, and reports on client meetings.
- Contributes to regulatory agency meetings.
- Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.
- Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.
- Acts as a resource for technical knowledge.
- Participates in quality improvement efforts to increase overall operational efficiency.
- Contributes to the building of the regulatory systems and infrastructure needed for GRAS.
- Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.
- Provides internal training in appropriate areas of expertise to other Departments.
- May act as a Line Manager to a small team, dependent on the