Manager, Regulatory Registration and Compliance

This is a fully remote position, open to applicants in Serbia, +1 more country.

📋 Description

• Formulate regulatory strategies in alignment with regulatory requirements.

• Create and review project plans, joint operating procedures, and templates.

• Support senior management in business growth through participation in business development meetings and contributions to proposals and budgets.

• Offer strategic regulatory advice, training, coaching, and mentorship to junior team members.

• Supervise staff members when necessary.

• Direct and manage complex regulatory projects, ensuring timely delivery of high-quality results and compliance.

• Oversee project setup activities and provide expert consultation to both internal and external stakeholders.

• Prepare, review, and manage regulatory submissions and documentation for the FDA, EMA, and other health authorities.

• Recognize and mitigate risks and resolve project-related issues.

• Ensure compliance with company processes and standards.

• Manage project resources, budgets, and team performance effectively.

• Assist in proposal development, budgeting, and client interactions.

• Establish and nurture relationships with clients, partners, and internal stakeholders.

• Stay updated on regulatory intelligence and communicate regulatory and legislative changes.

• Aid in client qualification, audit preparedness, and responses to findings.

• Supervise vendor qualification and performance.

• Propel process enhancements and lead departmental and organizational change initiatives.

⛳️ Requirements

• A degree in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology.

• Experience in the pharmaceutical, CRO, or regulatory sectors.

• Background in a leadership or project management role.

• Understanding of EU regulatory frameworks and relevant legal and compliance requirements in the pharmaceutical industry, both locally and globally.

• Familiarity with ICH GCP/GVP and pertinent regulatory standards.

• Strong organizational abilities with the capacity to manage multiple projects and deadlines effectively.

• A collaborative approach and exceptional communication skills for engaging with clients and regulatory authorities.

• Proficient in English, both written and spoken.

• Experience with centralized procedures is a plus.

• Familiarity with regulatory databases and dossier management software is advantageous.

🏝️ Benefits

• Options for remote work.

• A flexible work environment.

• Opportunities for growth and development.

• Training, coaching, and mentorship programs.

• A collaborative and supportive team culture.

• The chance to impact global patient safety and pharmaceutical treatments.

• A diverse and inclusive workplace.

• Professional development through engagement in clinical research, pharmacovigilance, and quality consulting.