Senior Associate Regulatory Affairs

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

Working Pattern: Primarily remote with approximately one on-site team meeting per month.

Overview:

An exciting opportunity has arisen for a Senior Associate, Regulatory Affairs to support regulatory strategy and submission activities across a portfolio of pharmaceutical products. The successful candidate will work as part of a cross-functional team, helping ensure regulatory compliance and supporting product lifecycle management activities within a highly regulated environment.

This role is ideal for a regulatory affairs professional with experience in the pharmaceutical or biotechnology industry who is looking to broaden their regulatory expertise and contribute to product development and commercialization activities.

Key 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.

Key Activities

• 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.

Required Knowledge & Skills

• 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.
• Ability to interpret and communicate scientific and clinical information effectively.
• Strong organizational skills with the ability to manage multiple priorities.
• Excellent stakeholder management and communication abilities.

Education & Experience

• Master's degree in a scientific discipline; or
• Bachelor's degree in a scientific discipline plus a minimum of 2 years' relevant industry experience.

Preferred Candidate Profile

• Experience working within Regulatory Affairs in the pharmaceutical, biotechnology, or life sciences sector.
• Familiarity with marketing authorization applications and post-approval lifecycle activities.
• Experience collaborating with regulatory agencies and cross-functional teams.
• Strong attention to detail and commitment to regulatory compliance.

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.