Manager, Regulatory Registration and Compliance

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

📋 Description

• Formulate regulatory strategies in accordance with regulatory standards.

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

• Assist senior management in developing new business through participation in business development meetings and contributions to proposals and budgets.

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

• Lead and manage intricate regulatory projects.

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

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

• Identify risks, mitigate them, and resolve project-related issues.

• Ensure adherence to regulatory requirements, company processes, and standards.

• Manage project resources, budgets, team performance, timelines, and objectives.

• Support the development of proposals, budgeting, and client interactions.

• Cultivate and maintain relationships with clients, partners, and internal stakeholders.

• Track regulatory intelligence and relay updates on regulatory and legislative changes.

• Assist with client qualification, audit and inspection readiness, and address findings.

• Supervise vendor qualifications and performance.

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

• May have direct management responsibilities for team members.

⛳️ Requirements

• Bachelor’s degree in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology.

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

• Experience in a leadership or project management capacity.

• Familiarity with the EU regulatory landscape and relevant legal and regulatory requirements, both local and global, within the pharmaceutical sector.

• Understanding of ICH GCP/GVP and applicable regulatory standards.

• Outstanding organizational abilities to handle multiple projects and meet deadlines.

• Exceptional communication skills for engaging with clients and regulatory agencies.

• 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

• Opportunity for remote work.

• A collaborative and supportive workplace culture.

• Flexible working arrangements.

• Opportunities for professional growth.

• Access to training, coaching, and mentoring programs.

• Chance to engage in projects with a global impact.

• Work alongside a team of experts in clinical research, pharmacovigilance, and quality consulting.