Regulatory Affairs Specialist

We at Roche are looking for an experienced and motivated Regulatory Affairs Specialist to join our team. This role is responsible for providing regulatory support to the organization, ensuring that Roche is compliant with all applicable laws and regulations. The successful candidate should have an in-depth knowledge of US and International regulations, excellent communication skills, and a passion for helping our company succeed. If you have the experience and drive to make a difference, we’d love to hear from you.Qualifications:• Bachelor’s degree in a relevant field• At least 3 years of experience in regulatory affairs• Proven track record of success in a fast-paced and highly regulated environment• Knowledge of US and International regulations• Excellent communication, negotiation, and problem-solving skills• Ability to manage multiple projects and deadlines simultaneously• Strong organizational and time management skills

Responsibilities:

1. Develop and maintain regulatory strategies that ensure compliance with US and International regulations.
2. Monitor and assess changes to applicable regulations and recommend changes to internal policies to ensure compliance.
3. Prepare and submit regulatory documents and support materials to the appropriate authorities.
4. Liaise with internal stakeholders and external regulators to ensure successful regulatory submissions and approvals.
5. Perform due diligence reviews and evaluate data to ensure compliance.
6. Develop and maintain regulatory databases and tracking systems.
7. Keep abreast of industry trends and best practices in regulatory affairs.
8. Provide guidance and support to team members on regulatory matters.
9. Identify and develop processes to improve efficiency and reduce costs.
10. Prepare regulatory reports and presentations for management and stakeholders.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Welwyn Garden City, UK is £35,000 - £45,000 per annum. This range is based on salaries submitted to the site anonymously by employees and job seekers.

Roche Holding AG operates as a research healthcare company. It operates through the diagnostics and pharmaceuticals segments. The pharmaceutical segment refers to development of medicines in the field of oncology, immunology, ophthalmology, infectious diseases and neuroscience. The diagnostic segment refers to diagnosis of diseases through an in vitro diagnostics process.