Regulatory Affairs Specialist

About the Role

Our client is seeking an experienced Regulatory Affairs Specialist to join their team in Belfast , Northern Ireland. This critical role involves ensuring that the company's pharmaceutical products comply with all applicable national and international regulations. You will be responsible for preparing, submitting, and maintaining regulatory filings, liaising with health authorities, and providing regulatory guidance to internal departments. This position is ideal for a proactive and knowledgeable individual who is passionate about navigating the complex regulatory landscape of the pharmaceutical industry and ensuring patient access to safe and effective medicines.

Key Responsibilities

• Prepare and submit regulatory dossiers (e.g., MAAs, NDAs) to health authorities such as the MHRA, EMA, and FDA.
• Maintain existing product registrations and manage post-approval variations and renewals.
• Interpret regulatory guidelines and provide strategic advice to R&D, manufacturing, and marketing teams.
• Act as a primary point of contact with regulatory agencies, responding to inquiries and managing inspections.
• Review and approve promotional materials and product labelling for regulatory compliance.
• Monitor changes in the regulatory environment and assess their impact on the company's products and operations.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; Master's degree preferred.
• Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
• In-depth knowledge of global pharmaceutical regulatory requirements and submission processes.
• Experience with dossier preparation and submission using eCTD format.
• Excellent written and verbal communication skills, with strong attention to detail.
• Proven ability to manage multiple projects simultaneously and meet strict deadlines in the Belfast region.

Benefits

• Competitive salary and benefits package, including health, dental, and vision insurance.
• Generous annual leave allowance and company holidays.
• Opportunities for international travel and professional development.
• A dynamic and collaborative work environment within a growing pharmaceutical company.
• Pension scheme with employer contributions to support your future.