Regulatory Manager
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Poznan • 🇵🇱 Poland
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Swift
About the role
- Manage and develop a diverse team of regulatory professionals, fostering a motivating and productive work environment.
- Oversee HR aspects—from recruitment and professional development to performance management.
- Act as a trusted point of escalation for your team, ensuring challenges are met with swift, effective solutions.
- Lead the preparation, quality checking, and submission of complex Pharma and Vaccines CMC regulatory packages.
- Maintain the highest standards of compliance with ever-evolving global regulatory guidelines.
- Proactively identify and mitigate risks to guarantee timely project completion.
- Support the implementation of digital tools and technologies that streamline regulatory processes.
- Champion continuous process improvement initiatives, driving efficiency across all levels of the regulatory submissions.
- Build and nurture robust relationships with global partners, ensuring seamless communication in a matrix environment.
- Represent the regulatory function in strategic discussions, working across departments to achieve common goals.
Requirements
- A Bachelor’s degree (or higher) in a Scientific or Technical field.
- Proven expertise in regulatory affairs with a strong emphasis on CMC-related activities.
- Demonstrated experience managing or working with direct reports.
- A proactive approach to leveraging digital technologies to enhance team performance and process efficiency.
- Experience guiding teams through change with strong problem-solving and negotiation skills.
- Fluent proficiency in English.
- Exceptional interpersonal skills to drive collaboration and maintain strong stakeholder relationships.
- Ability to independently manage multiple projects, navigating complex tasks and shifting priorities with a disciplined, logical work style.
Benefits
- Attractive benefits including an annual bonus, recognition awards for outstanding performance, and holiday benefits.
- Comprehensive life insurance, private medical package (with preventive healthcare services), and pension plan.
- Development opportunities through internal and external training platforms.
- A chance to build your digital skillset while managing significant regulatory submissions.
- A modern office with creative spaces and flexible working arrangements (hybrid model: 2–3 days/week in the office).
- A friendly, supportive community that values diversity, ensures work-life balance, and flexible work solutions.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsCMC-related activitiesproject managementprocess improvementrisk mitigationquality checkingsubmission of regulatory packagesdigital technologies
Soft skills
leadershipproblem-solvingnegotiationinterpersonal skillscollaborationcommunicationteam managementproactive approachorganizational skillsadaptability