Regulatory Affairs Specialist

Join our team and make a difference as our Regulatory Affairs Specialist at Roche! We are looking for a highly motivated individual who brings an innovative and creative mindset to the team. The ideal candidate must have a proven track record of success in the Regulatory Affairs field and possess the following qualifications:• Bachelor’s Degree in Life Sciences, Regulatory Affairs, or related field• At least 5 years of experience in Regulatory Affairs• In-depth knowledge of regulatory requirements, guidelines, and procedures• Strong organizational and communication skills• Ability to multitask and manage multiple projects simultaneously• Self-motivated and able to work independentlyIf you are a hardworking professional who thrives in a fast-paced environment and are passionate about working in the Regulatory Affairs field, we want to hear from you!

Responsibilities:

1. Develop and maintain regulatory strategies to ensure regulatory compliance.
2. Monitor and analyze current regulatory policies and procedures to ensure ongoing compliance.
3. Prepare and submit regulatory documents for local, regional, and global markets.
4. Collaborate with internal and external partners to ensure timely submission and approval of regulatory documents.
5. Manage and track regulatory submissions and related activities.
6. Maintain detailed records of regulatory data and processes.
7. Provide guidance and support on regulations, procedures, and practices.
8. Ensure that regulatory documents are up-to-date and accurate.
9. Monitor industry trends and developments related to regulatory affairs.
10. Contribute to the development of regulatory strategies.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Indianapolis, IN, USA is $77,425 - $110,320 per year. This range is based on the most recent salary surveys from local employers and employees in the area.

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.