Regulatory Affairs Manager
- glasgow, scotland, G1 1DA, United Kingdom
- Permanent·Hybrid
- Full time
- £70,000 - £70,000 Per Annum
Job Description
About the Role
Our client is seeking an experienced and strategic Regulatory Affairs Manager to oversee regulatory submissions and compliance for their pharmaceutical products. This role, based in Glasgow , operates on a hybrid model, combining remote flexibility with essential office-based collaboration. You will be responsible for interpreting and implementing global regulatory requirements, ensuring that all product development and marketing activities adhere to the highest standards. Your expertise will be vital in navigating complex regulatory landscapes, facilitating timely approvals, and maintaining market access for innovative therapies. This position demands a proactive approach, strong leadership skills, and a deep understanding of pharmaceutical regulations to support the company's growth and success.
Key Responsibilities
- Develop and execute regulatory strategies for product development and lifecycle management.
- Prepare, submit, and manage regulatory filings (e.g., NDAs, MAAs, variations) in various global markets.
- Liaise with regulatory authorities (e.g., MHRA, FDA, EMA) to facilitate submissions and respond to queries.
- Ensure ongoing compliance with relevant pharmaceutical regulations and guidelines.
- Provide regulatory guidance and support to internal teams, including R&D, manufacturing, and marketing.
- Monitor regulatory changes and assess their impact on the company's product portfolio.
Requirements
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs .
- Proven track record of successful regulatory submissions and approvals in major markets.
- In-depth knowledge of global regulatory guidelines and submission processes.
- Strong leadership, project management, and communication skills.
- Ability to work effectively in a hybrid environment, balancing remote and office-based responsibilities.
Benefits
- Competitive salary and performance-related bonus.
- Comprehensive private medical insurance.
- Company car or substantial travel allowance.
- Generous annual leave entitlement.
- Opportunities for career advancement and international exposure.
- A dynamic work environment that values expertise and strategic thinking.