Senior Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a highly experienced Senior Regulatory Affairs Specialist to join their team in Bradford . This pivotal role ensures that our client's pharmaceutical products comply with all relevant national and international regulations throughout their lifecycle. In this hybrid position, you will manage regulatory submissions, liaise with health authorities, and provide strategic guidance on regulatory compliance. You will work closely with R&D, quality assurance, and commercial teams to facilitate the timely approval and market access of new medicines. This is an excellent opportunity for a seasoned regulatory professional to make a significant impact within a respected pharmaceutical organization.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., MAAs, NDAs, variations) to health authorities in various global markets.
• Provide strategic regulatory guidance and support to product development teams and commercial functions.
• Interpret and advise on complex regulatory requirements, guidelines, and standards.
• Act as the primary point of contact for regulatory agencies during submissions and inspections.
• Maintain regulatory compliance by monitoring changes in regulations and implementing necessary updates.
• Review promotional materials and labeling to ensure compliance with regulatory requirements.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 5-7 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of global regulatory requirements (e.g., EMA, FDA) and submission processes.
• Proven experience in preparing and managing regulatory submissions for various product types.
• Excellent analytical, written, and verbal communication skills.
• Ability to work effectively in a hybrid environment and collaborate across multiple departments.

Benefits

• Competitive salary and attractive bonus structure.
• Comprehensive health, dental, and vision insurance.
• Generous holiday allowance and flexible working options.
• Professional development and training opportunities.
• Pension scheme and life insurance.