Roles & Responsibilities:
• Develop global regulatory project plans for moderate-to-high complexity submissions (CTA/IND, MAA/NDA/BLA, HA meetings/Scientific Advice).
• Track regulatory deliverables, ensuring timely submission and life cycle management of products.
• Collaborate with Global Regulatory Lead, Regulatory Affairs Manager, and Submission Manager to execute submissions.
• Orchestrate Submission Task Force activities, manage risks, interdependencies, and resolve issues impacting timelines.
• Set up hypercare for critical submissions to Health Authorities.
• Consolidate budget planning and track actuals for regulatory projects; coordinate with project controllers and global project management.
• Support operational aspects of in-licensing/out-licensing deals, including asset transfer planning and internal activity initiation.
• Improve project management tools, templates, and ensure compliance with Health Authority requirements.
• Maintain strong collaboration across cross-functional teams and matrix organization stakeholders.
• Ensure documentation and dossier readiness, including CPPs, GMP Certificates, MLs, AtOs, AFs, CLs, PoAs, and legalization frameworks.
• Manage regulatory affairs knowledge for post-approval changes, dossier types, and main global procedures.
Qualification:
• Degree in Life Sciences, Medicine, Pharmacy, PharmD, or related discipline (minimum MSc or equivalent; PhD preferred).
• Advanced training in portfolio and project management preferred.
Experience:
• 8–14 years of work experience in pharmaceutical, regulatory authority, or R&D environments.
• Minimum 6–8 years in regulatory affairs or regulatory project management.
• Hands-on experience with global regulatory submissions and life cycle management.
• Contributor-level experience with RIM and EDMS RA applications.
Skills:
• Excellent written and spoken English communication.
• Strong project management, organizational, and result-oriented skills.
• Ability to influence teams, work collaboratively in a matrix organization, and take ownership of deliverables.
• Strong customer orientation, problem-solving, and strategic thinking.
• Knowledge of EU & international regulatory requirements and frameworks.
About the Organisation:
A leading global pharmaceutical and life sciences company focused on innovative solutions for healthcare, life sciences, and electronics. The organization fosters a culture of curiosity, inclusion, and collaboration, emphasizing scientific excellence, regulatory compliance, and patient-centric innovation. Employees are encouraged to take ownership, innovate, and contribute to impactful global health outcomes.
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