Manager, Regulatory Registration and Compliance

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

📋 Description

• Formulate regulatory strategies in accordance with regulatory requirements.

• Create and evaluate Project Plans, joint operating procedures, and templates.

• Support senior management during business development meetings, proposals, and budgeting processes.

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

• Oversee staff management as needed.

• Lead and manage intricate regulatory projects, ensuring prompt, high-quality delivery and compliance.

• Coordinate project setup activities and provide expert advice to both internal and external stakeholders.

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

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

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

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

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

• Stay updated on regulatory intelligence and relay important regulatory and legislative changes.

• Aid in client qualification, audit and inspection readiness, and response to findings.

• Oversee the qualification and performance of vendors.

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

⛳️ Requirements

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

• Experience in the pharmaceutical, CRO, or regulatory fields, including leadership or project management roles.

• 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 applicable regulatory standards.

• Exceptional organizational abilities, capable of managing multiple projects and deadlines.

• A collaborative mindset with excellent communication skills for effective interaction with clients and regulatory entities.

• Proficient in English, both written and verbal.

• Experience with centralized procedures is a plus.

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

🏝️ Benefits

• Availability for remote work.

• A collaborative and supportive team environment.

• Flexible working arrangements.

• Opportunities for professional growth.

• Access to training, coaching, and mentoring programs.

• Chance to engage in global projects that have a real impact on patient safety.