Nestlé: Good food, Good life | Nestlé Global

Senior Regulatory Affairs Specialist – Pharma

ComplianceComplianceFull TimeRemoteTeam 5,001-10,000H1B SponsorCompany Site LinkedIn

Location

Colorado + 2 more

Posted

166 days ago

Salary

$95K - $120K / year

Bachelor Degree7 yrs expEnglishAssembly

Job 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

Job 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