Regulatory Affairs Specialist - Pharmaceutical

About the Role

Our client is seeking a detail-oriented Regulatory Affairs Specialist to join their bustling pharmaceutical operations in Birmingham . This role is critical in ensuring that all pharmaceutical products meet stringent national and international regulatory standards before they reach the market. You will be instrumental in preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulations. This is an excellent opportunity to contribute significantly to product development and compliance within a well-established pharmaceutical company that prioritizes innovation and patient safety.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and renewals to health authorities.
• Liaise directly with regulatory agencies such as the MHRA, EMA, and FDA on behalf of the company.
• Provide regulatory guidance and support to R&D, manufacturing, and marketing teams.
• Monitor and interpret regulatory changes, assessing their impact on company products and processes.
• Manage and maintain regulatory compliance records and databases.
• Conduct internal audits and training sessions on regulatory compliance matters.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• 3-5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Demonstrated experience with regulatory submissions and interactions with health authorities.
• Strong understanding of global pharmaceutical regulatory requirements and guidelines.
• Excellent written and verbal communication skills, with a keen eye for detail.
• Ability to manage multiple projects simultaneously and meet tight deadlines.

Benefits

• Competitive salary and comprehensive benefits package.
• Opportunities for international travel for regulatory conferences and meetings.
• Professional development and training in advanced regulatory strategies.
• Generous annual leave and pension scheme.
• A supportive and collaborative work environment in the heart of Birmingham .