Senior Regulatory & Pharmacovigilance Specialist - Remote

About the Role

We are seeking a Senior Regulatory & Pharmacovigilance Specialist to join our team remotely. In this role, you will be responsible for developing regulatory strategies and managing pharmacovigilance deliverables, ensuring compliance with industry standards. You will work closely with various stakeholders, including clients and regulatory authorities, to drive project success.

What You'll Do

• Act as the Local Contact Person for Pharmacovigilance in your designated country.
• Lead projects of medium to high complexity, ensuring effective coordination and management of regulatory deliverables.
• Develop strategies and manage setup activities, including Project Management Plans and core documents.
• Provide strategic input to clients and internal teams, identifying and mitigating risks promptly.
• Support proposal development and budget input, representing the department in business development meetings.
• Prepare and review client invoices and vendors’ project invoices.
• Foster professional relationships with internal and external contacts to ensure efficient service delivery.
• Stay updated on changing regulatory requirements and maintain the regulatory intelligence database.

Requirements

• Bachelor's Degree in Chemistry, Life Sciences, Nursing, or equivalent experience.
• Strong experience in the pharmaceutical or CRO industry, with knowledge of ICH GCP and GVP regulations.
• Fluency in English, both written and verbal; proficiency in German, French, or Italian is a plus.
• Excellent planning and organizational skills, with strong attention to detail.
• Ability to work in a fast-paced, deadline-oriented environment.

Nice to Have

• Experience with regulatory bodies or in a similar role.
• Knowledge of local regulations for the territories of competency.
• Experience in training and mentoring junior staff.

What We Offer

• Training and career development opportunities.
• A supportive and friendly working environment.
• Opportunities to work with colleagues globally, with English as the company language.
• A focus on diversity, equity, and inclusion within the workplace.
• Strong emphasis on personal and professional growth.