Regulatory Affairs Specialist - Pharmaceutical

About the Role

Our client is seeking an experienced Regulatory Affairs Specialist to contribute to their esteemed pharmaceutical division in Newcastle upon Tyne . This role is crucial for ensuring that all products meet stringent regulatory standards across various global markets. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulations. Join a forward-thinking company that is committed to advancing healthcare solutions and offers a collaborative environment where your expertise in regulatory compliance will be highly valued, impacting the accessibility of critical medicines.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations) to health authorities in various regions.
• Interpret and provide guidance on regulatory requirements and guidelines to internal teams, including R&D, manufacturing, and marketing.
• Maintain up-to-date knowledge of the global regulatory landscape and communicate changes and their implications.
• Manage post-approval regulatory activities, including annual reports, renewals, and labeling updates.
• Liaise with regulatory agencies during inspections and respond to queries from health authorities.
• Support the development of regulatory strategies for new product registrations and lifecycle management.

Requirements

• Bachelor's or Master's degree in pharmacy, chemistry, biology, or a related scientific discipline.
• Minimum of 3-5 years of experience in pharmaceutical regulatory affairs .
• Proven track record of successful regulatory submissions and approvals.
• Strong understanding of global regulatory guidelines (e.g., FDA, EMA, MHRA).
• Excellent written and verbal communication skills, with a keen eye for detail and accuracy.
• Ability to work effectively both independently and as part of a cross-functional team in Newcastle upon Tyne .

Benefits

• Competitive annual salary and potential for performance-based bonuses.
• Hybrid working model offering flexibility between home and office.
• Comprehensive health insurance, including private medical cover.
• Contributory pension scheme and life assurance.
• Access to professional development programs and opportunities for career advancement within the pharmaceutical sector.