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 established regulatory requirements

• Create and assess project plans, collaborative operating procedures, and standard templates

• Direct and manage intricate regulatory projects

• Oversee project initiation activities and offer expert advice to both internal and external stakeholders

• Prepare, evaluate, and supervise regulatory submissions and documentation for FDA, EMA, and other health authorities

• Recognize and alleviate risks, address project challenges, and ensure adherence to company processes and standards

• Manage project resources, budgets, and team performance to achieve timelines and objectives

• Assist in business development through proposal crafting, budgeting, client interactions, and participation in business development meetings

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

• Line manage personnel as necessary

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

• Monitor regulatory developments and convey updates on regulatory and legislative matters

• Aid in client qualification, audit and inspection preparedness, and address findings

• Supervise vendor qualification and performance assessments

• Propel process enhancements and spearhead departmental and organizational change initiatives

⛳️ Requirements

• University degree in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology

• Experience in the pharmaceutical, CRO, or regulatory sectors

• Demonstrated experience in a leadership or project management capacity

• In-depth understanding of the EU regulatory landscape and relevant legal and other requirements, both locally and globally, within the pharmaceutical industry

• Familiarity with ICH GCP/GVP and relevant regulatory standards

• Exceptional organizational abilities with the capacity to manage multiple projects and deadlines

• A collaborative approach and outstanding communication skills for engaging with clients and regulatory agencies

• Proficient command of English, both written and verbal

• Familiarity with centralized procedures is advantageous

• Experience with regulatory databases and dossier management software is a plus

🏝️ Benefits

• Flexible working arrangements, including options for remote work

• Opportunities for growth and professional development

• Access to training, coaching, and mentorship programs

• A collaborative and supportive work culture

• The chance to contribute to patient safety and global pharmaceutical initiatives