What You’ll Do
- Drive Integration Activities: Post-merger and acquisition, manage the regulatory integration process, generate intelligence for pre-integration assessments, support Unit Heads during due diligence, manage project integration, and ensure smooth transitions.
- Review and Compliance: Assist the Manager and Regional team in reviewing regulatory applications, ensure high standards and accuracy, and support the development of junior team members.
- Strategic Submissions: Develop strategies for complex regulatory submissions, engage with health authorities to align on regulatory strategies, and handle complex submissions independently when necessary.
- Process Improvement: Act as the process owner for complex regulatory processes, focus on process improvement and simplification.
- Regulatory Updates: Keep oversight of regulatory updates, train and organize discussions cross-functionally, and ensure legislative compliance.
- Cross-Functional Meetings: Act as a delegate for the Manager in cross-functional meetings and approvals.
- Health Authority Inspections: Participate in preparation and conduct health authority inspections.
- Team Coaching: Mentor junior team members on regulatory requirements, contribute to the induction of new team members.
- Deputy Role: Act as a deputy to the Manager/Sr. Manager during absences.
About You
We seek highly motivated individuals passionate about making a meaningful difference in patients’ lives.
Qualifications:
- Graduate/Post-Graduate in any discipline of science, preferably life science or Pharmacy.
Knowledge, Skills & Experience:
- Significant experience in regulatory affairs for life cycle maintenance activities in UK/IE/EU markets.
- Practical experience with CTD, specifically module 2-3 writing and review.
- Commercial awareness and understanding of cross-functional dependencies.
- Knowledge of regional regulatory guidelines (CTD/ICH/eCTD).
- Strong project management and communication skills.
- Collaborative approach, strategic mindset, and positive attitude.
- Demonstrated drive, urgency, and solution-oriented decision-making.
- Positive, can-do attitude, embracing change and continuous improvement.
- Open, honest, and respectful cooperation across all business functions.
- Ability to thrive in a growing, unique, and inclusive work environment.
