Manager, Regulatory Affairs

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Establish and maintain robust relationships with clients while identifying opportunities to enhance support services.

• Oversee and assist with regulatory activities related to marketing authorizations, which include applications, renewals, and variations.

• Prepare, review, and compile necessary documentation for regulatory affairs initiatives.

• Engage directly with clients and Health Authorities.

• Assist in scientific advice procedures and advocate for clients during interactions with authorities.

• Plan and execute client projects in alignment with KPIs, coordinating with colleagues and external partners as required.

• Offer guidance on regulatory strategy and procedure management to both clients and team members.

• Stay informed about regulatory changes and disseminate insights throughout the team.

• Conduct seminars, lectures, and knowledge-sharing sessions.

• Contribute to the implementation of strategies, process enhancements, and commercial and business development initiatives.

• Aid in budget management by providing accurate reporting and project insights.

⛳️ Requirements

• A university degree in Life Sciences or a related field.

• Demonstrated experience or clear capability in regulatory affairs or a comparable area.

• In-depth knowledge and practical experience in regulatory services, preferably across both human and veterinary medicinal products.

• Experience managing intricate regulatory tasks and supporting client-facing projects.

• Competence in working across various sectors including medicines, cosmetics, food supplements, and herbal products.

• Strong organizational abilities to manage multiple priorities and meet deadlines effectively.

• An analytical and structured mindset with the confidence to operate independently.

• Excellent problem-solving skills along with a pragmatic and service-oriented approach.

• Capability to mentor and guide junior colleagues and lead smaller projects.

• Exceptional relationship management skills with both internal teams and external clients.

• Outstanding written and verbal communication skills, with the ability to present confidently and sway decision-makers.

• Proficiency in business-level English.

🏝️ Benefits

• Benefit offerings outside the US may differ by country and will align with local market practices.

• Commitment to equal employment opportunities and non-discriminatory practices in recruiting, training, compensation, benefits, promotions, and transfers.

• Provision of reasonable accommodations throughout the employment process.