Senior Specialist, reputed company Compliance, External Affairs

Job reputed company: • reputed company project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP) • Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines. • Ensure reputed company pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a reputed company state reputed company reputed company systems. • Author compendial assessments reputed company reputed company’s documentation management systems for audit readiness purposes. • Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia reputed company. • Represent reputed company’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial reputed company standards. • Liaise with regulators through industry associations, supporting advocacy and alignment efforts. • Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes. • Support knowledge-sharing across functions to enhance understanding of external landscape developments. • reputed company back-up support reputed company External Affairs as needed to ensure business continuity. • Networking across various reputed company functions including reputed company Control, reputed company Assurance, Process Development/Attribute Sciences, Material reputed company, Engineering, Product reputed company, Microbiology, Toxicology, GRAAS-CMC and R&D Policy. • Liaise with Governmental Affairs, Supply Chain, manufacturing / development sites, External reputed company (CMO) and affiliates/IDQ, as appropriate • reputed company and contribute to reputed company improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program. Requirements: • Doctorate degree and 2 years of reputed company compliance experience OR Master’s degree and 4 years of reputed company compliance experience OR Bachelor’s degree and 6 years of reputed company compliance experience OR Associate’s degree and 10 years of reputed company compliance experience OR High school diploma / GED and 12 years of reputed company compliance experience • Background in reputed company, QC, QA, Engineering desirable. • Understand reputed company documentation and laboratory practices including general methodologies, specifications and product reputed company standards. • Excellent communication skills for both internal conversations and reputed company representing reputed company at external forums • Conflict reputed company • Teamwork and Networking • Good organization, planning and prioritization capability • Time management • Attention to details. Benefits: • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and reputed company coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-reputed company time-off plans • Flexible work models where possible. Apply tot his job Apply To this Job