Senior Regulatory Associate, PM

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🌵 Arizona – Remote

Although this job is listed in Arizona, this company may be open to hiring remote in other states.

🦞 Maine – Remote

Although this job is listed in Maine, this company may be open to hiring remote in other states.

+3 more states

🌵 Arizona – Remote 🦞 Maine – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

💵 $47k - $79.9k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Syneos Health

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Performs detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance. • Creates and edits regulatory reports, conducts quality control review of documents, and may include collection and analysis of data to produce reports. • Prepares and submits full applications to ensure compliance with government acts and regulations. • Undertakes project specific activities with minimal supervision and conducts quality control reviews of documents. • Attends client meetings and builds client relationships in support of projects. • Assists in training and mentoring of team members depending upon project requirements.

🎯 Requirements

• 3-5 years of Regulatory Experience within Industry • Smartsheets • Veeva Vault RIM • BS/BA degree or equivalent practical experience • Excellent interpersonal / communication skills • Advanced skills in Microsoft Office Applications • Strong analytical skills • Fluent in speaking, writing, and reading English • In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards.

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Flexible paid time off (PTO) and sick time • Eligibility to earn commissions/bonus based on company and individual performance