Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is looking for a proficient Regulatory Affairs Specialist to join their dedicated, remote-based team. In this vital role, you will be responsible for ensuring that all pharmaceutical products meet the stringent requirements of regulatory authorities worldwide. You will navigate complex regulatory landscapes, prepare submission documents, and provide expert guidance on regulatory strategies to support product development and lifecycle management. This is an excellent opportunity for a seasoned regulatory professional to contribute to global health initiatives from a remote location, working with a company that values expertise, efficiency, and compliance in the dynamic pharmaceutical sector.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for product registrations, variations, and renewals in various global markets.
• Monitor and interpret regulatory guidelines and provide strategic advice to R&D, manufacturing, and commercial teams.
• Ensure compliance with national and international pharmaceutical regulations, including GMP, GLP, and GCP.
• Manage regulatory agency communications, respond to queries, and facilitate inspections.
• Conduct regulatory intelligence activities to stay updated on evolving regulations and competitor strategies.
• Support the development and implementation of global regulatory strategies for new and existing products.
• Liaise with cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• In-depth knowledge of regulatory requirements in key markets (e.g., UK, EU, US).
• Proven experience in preparing and filing various types of regulatory submissions (e.g., MAA, NDA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple projects, and meet strict deadlines in a remote setting.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive benefits package including health, dental, and vision insurance.
• Generous annual leave allowance and public holidays.
• Professional development opportunities and support for certifications.
• Fully remote work arrangement, offering flexibility and autonomy.