Remote Senior Regulatory Affairs Specialist

Planet Pharma; Chicago (IL); Hybrid; GBP 45,000 - 65,000; Full time

Job summary

Planet Pharma is seeking a Senior Associate, Regulatory Affairs to drive regulatory strategy and submissions across a pharmaceutical portfolio. You will work with cross-functional teams to ensure regulatory compliance and support lifecycle management in a highly regulated environment.

The ideal candidate has pharmacovigilance or regulatory affairs experience in pharma/biotech and aims to expand regulatory expertise while contributing to product development and commercialization activities.

Qualifications

• Strong understanding of regulatory affairs principles within the pharmaceutical industry.
• Working knowledge of relevant regulations, guidelines, policies, and SOPs.
• Understanding of drug development and product lifecycle management.
• Knowledge of national and regional regulations governing medicinal products.

Responsibilities

• Support the development and execution of local and regional regulatory strategies.
• Plan, prepare, and manage regulatory submissions in accordance with local regulations and internal standards.
• Ensure compliance with applicable regulatory requirements throughout the product lifecycle.
• Provide regulatory guidance to support product development, approvals, and lifecycle maintenance.
• Develop and maintain local product labeling in line with legislative requirements.
• Act as a key point of contact with health authorities and regulatory agencies.
• Monitor changes in regulatory legislation and communicate potential impacts to internal stakeholders.
• Support regulatory compliance commitments, including post-approval requirements and agency commitments.
• Participate in the preparation and submission of safety-related communications when required.Review and approve promotional and non-promotional materials for regulatory compliance.
• Contribute to regulatory filing plans for marketing authorizations and lifecycle management activities.
• Coordinate local execution of filing plans and submission timelines.
• Ensure high-quality regulatory submissions are delivered on schedule.
• Create, review, and approve labeling documentation and associated artwork.
• Collaborate with cross-functional teams to support clinical study activities and regulatory requirements.
• Monitor the external regulatory landscape and provide input into regulatory decision-making.
• Support compliance activities relating to ongoing regulatory obligations and commitments.

Skills

Regulatory affairs

Regulatory guidelines

Drug development

Regulatory compliance

Stakeholder management

Project management

Education

Master's degree in a scientific discipline

Bachelor's degree in a scientific discipline

Job description

Planet Pharma is seeking a Senior Associate, Regulatory Affairs to drive regulatory strategy and submissions across a pharmaceutical portfolio. You will work with cross-functional teams to ensure regulatory compliance and support lifecycle management in a highly regulated environment.

The ideal candidate has pharmacovigilance or regulatory affairs experience in pharma/biotech and aims to expand regulatory expertise while contributing to product development and commercialization activities.