Senior Regulatory Affairs Specialist – Pharma

Job not on LinkedIn

October 1

⛰️ Colorado – Remote

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

🌽 Illinois – Remote

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

+1 more states

⛰️ Colorado – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote

💵 $95k - $120k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

Nestle

WebsiteLinkedInAll Job Openings

B2C • Retail

Nestle is a Swiss multinational food and beverage company that produces and markets a wide range of packaged foods and beverages, including coffee, bottled water, dairy products, infant nutrition, confectionery, frozen foods, and pet care brands. The company sells its products globally through retail and foodservice channels, operates extensive manufacturing and supply-chain operations, and focuses on nutrition, health, and wellness initiatives.

5001 - 10000 employees

👥 B2C

🛒 Retail

📋 Description

• Oversee end-to-end dossier execution activities • Collaborate with Regulatory Leads and cross-functional content authors • Serve as a Regulatory Operations representative on global submission filings teams • Ensure accurate assembly of submission dossiers • Perform document editing to meet ICH eCTD specifications • Execute regulatory information management tasks • Provide Regulatory Intelligence support • Develop and report Regulatory Operations metrics and dashboards • Participate in the development and training on Regulatory Operations processes • Contribute to systems/submission processes and improvements

🎯 Requirements

• Bachelor’s degree, or equivalent work experience • 7+ years of Regulatory Operations experience • Understanding of the pharmaceutical drug development and global Regulatory submissions • 3+ years of eCTD publishing • Expertise utilizing eDMS applications and publishing systems • Knowledgeable of 21 CFR Part 11 compliance • Proficiency in MS Office: MS Word, MS Excel, Adobe Acrobat • Demonstrated agility and adaptability during times of ambiguity • Excellent verbal, written, and interpersonal communication skills • Ability to work independently and collaboratively in a fast-paced environment • Project management skills • Hands-on vendor management experience

🏖️ Benefits

• 401k with company match • healthcare coverage • performance-based incentives • opportunities for professional development and learning • benefits that support physical, financial, and emotional wellbeing