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 requirements.

• Develop and assess project plans, joint operating procedures, and templates.

• Support senior management in new business ventures through business development meetings, proposals, and budget preparation.

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

• Oversee and coordinate intricate regulatory projects to guarantee prompt, high-quality delivery and compliance.

• Manage project initiation activities and provide expert advice to both internal and external stakeholders.

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

• Identify and address risks, resolve project challenges, and ensure compliance with company processes and standards.

• Manage project resources, budgets, and team performance in alignment with timelines and goals.

• Assist in client engagement and proposal formulation.

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

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

• Facilitate client qualification, audit and inspection preparedness, and responses to findings.

• Supervise vendor qualification and performance.

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

• May have direct managerial responsibilities for staff members.

⛳️ Requirements

• Degree in Natural Sciences, Chemistry, Medicine, Pharmacy, or Pharmacology.

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

• Background in a leadership or project management capacity.

• Familiarity with EU regulatory frameworks and relevant legal requirements in the pharmaceutical industry.

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

• Exceptional organizational abilities to manage multiple projects and deadlines.

• Strong communication skills for effective collaboration with clients and regulatory agencies.

• Proficient in English, both written and verbal.

• Experience with centralized procedures is advantageous.

• Familiarity with regulatory databases and dossier management software is a plus.

🏝️ Benefits

• Availability of remote work.

• A collaborative and supportive team atmosphere.

• Flexible work culture.

• Opportunities for growth and professional development.

• Training, coaching, and mentoring opportunities.

• An international work environment.

• Chance to contribute to patient safety and pharmaceutical treatments.

• A dedicated team of experts in clinical research, pharmacovigilance, and quality consulting.