XE
Xcel EnergyRegulatory Policy Specialist
Regulatory Policy Specialist developing regulatory case filings and strategies at Xcel Energy. Collaborating with senior management to ensure compliance and effective communication with stakeholders.
GS
Hybrid Senior Regulatory Specialist, New Registration CMC, CMC Excellence
Posted last month
About the role
- Managing multiple CMC new files and CTA assignments for Pharma, Biopharm and Vaccines products including response to questions from Agency;
- Define and agree regulatory strategy, complete data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements;
- Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;
- Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements;
- Effective communication also in a digital context, including virtual meetings and digital platforms;
- Act as subject matter expert in regulatory processes;
- Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems;
- Supporting digital transformation through active participation in building digital skills;
Requirements
- Extensive experience in regulatory affairs, pharmaceutical industry (familiarity with CMC regulatory procedures and ICH CTD documentation)
- Bachelor’s or Master’s degree in biotechnology, pharmacy, chemistry or other related science or technical field
- Attention to details, excellent organization and time management skills
- Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
- Understanding of the pharmaceutical industry, drug development environment and regulatory processes.
- Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts
- Mindset that embraces digital transformation and innovation by being adaptable, forward-thinking, and eager to explore new possibilities in the ever-evolving digital landscape
- Veeva Vault knowledge would be an asset
Benefits
- Career at one of the leading global healthcare companies
- Maternity cover
- Hybrid work ( 2/3 days per week from the office)
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
- Sports cards (Multisport)
- Possibilities of development within the role and company’s structure
- Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits every day
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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