Manager, Regulatory Registration and Compliance
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Job Description
Regulatory compliance manager leading pharmaceutical submissions and complex regulatory projects at PrimeVigilance. Guiding clients and teams across global pharmacovigilance and patient-safety programs.
Responsibilities:
- Develop regulatory strategies based on regulatory requirements
- Prepare and review project plans, joint operating procedures, and templates
- Assist senior management with new business development through BDM participation and proposal/budget contributions
- Provide strategic regulatory guidance, training, coaching, and mentoring to junior members
- Lead and coordinate complex regulatory projects
- Manage project setup activities and guide internal and external stakeholders
- Prepare, review, and oversee regulatory submissions and documentation for FDA, EMA, and other health authorities
- Identify and mitigate risks and resolve project issues
- Ensure compliance with regulatory requirements, company processes, and standards
- Manage project resources, budgets, team performance, timelines, and objectives
- Support proposal development, budgeting, and client engagements
- Build and maintain relationships with clients, partners, and internal stakeholders
- Monitor regulatory intelligence and communicate regulatory and legislative updates
- Support client qualification, audit and inspection readiness, and responses to findings
- Oversee vendor qualification and performance
- Drive process improvements and lead departmental and organizational change initiatives
- May line manage members of staff
Requirements:
- University education in Natural Sciences, Chemistry, Medicine, Pharmacy or Pharmacology
- Experience in the pharmaceutical, CRO, or regulatory sector
- Experience in a leadership or project management role
- Knowledge of the EU regulatory area and applicable legal and other requirements, both local and global, within the pharmaceutical industry
- Knowledge of ICH GCP/GVP and applicable regulatory requirements
- Excellent organizational skills with the ability to manage multiple projects and deadlines
- Excellent communication skills for liaising with clients and regulatory bodies
- Advanced knowledge of English, both written and verbal
- Experience with centralised procedures advantageous
- Experience with regulatory databases and dossier management software advantageous
Benefits:
- Remote work available
- Collaborative and supportive work environment
- Flexibility
- Growth opportunities
- Training, coaching, and mentoring
- Opportunity to work on projects with global reach
- Collaborative team of experts in clinical research, pharmacovigilance, and quality consulting
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