Regulatory Affairs Manager

Are you passionate about driving regulatory strategies that pave the way for life-saving advancements in healthcare? TFS HealthScience invites you to take on the role of Regulatory Affairs Manager, where you'll lead CMC regulatory initiatives and contribute to our mission of improving the lives of patients with rare oncology-related diseases.

Sponsored-based in Sweden, with remote work options available.

About Us:

TFS HealthScience is a leading mid-sized Contract Research Organization (CRO), headquartered in Sweden. With a commitment to excellence and innovation, we partner with biotechnology and pharmaceutical companies to deliver high-quality solutions that make a difference in patients' lives.

About the Opportunity:

As a Regulatory Affairs Manager at TFS HealthScience, you'll be instrumental in guiding the regulatory path for our sponors oncology drugs. You'll oversee CMC regulatory activities, ensuring compliance with global standards and driving successful NDA submissions.

Key Responsibilities:

- Provide expert regulatory CMC guidance to cross-functional teams, integrating regulatory requirements into product development plans.

- Collaborate closely with internal and external stakeholders, ensuring alignment on regulatory strategies and activities.

- Act as the regulatory representative wthin cross-functional submission teams, facilitating smooth communication and coordination.

- Lead the planning and preparation of regulatory CMC sections for NDA submissions, ensuring accuracy and completeness.

- Prepare comprehensive responses to regulatory inquiries related to CMC activities, maintaining a high standard of documentation.

- Manage administrative tasks associated with NDA preparation, ensuring timelines are met and deliverables are of high quality.

Qualifications:

- Bachelor's or Master's degree in life sciences or related field.

- Experience in regulatory affairs within the pharmaceutical industry, with a focus on CMC activities.

- Proven track record in NDA development and submissions, with a strong understanding of drug product development.

- In-depth knowledge of GMP guidelines, global regulatory requirements, and US submission processes.

- Strong analytical skills and the ability to work independently, translating organizational goals into actionable CMC deliverables.

- Experience as a regulatory affairs representative in cross-functional teams, with a focus on collaboration and communication.

- Excellent written and verbal communication skills in English.

As a Regulatory Affairs Manager within CMC:

- Uphold TFS HealthScience's values of integrity, innovation, and excellence.

- Foster strong relationships with team members and stakeholders, promoting collaboration and mutual respect.

- Thrive in a dynamic, fast-paced environment, with a proactive approach to problem-solving and goal-setting.

- Demonstrate flexibility, adaptability, and resilience in navigating complex regulatory landscapes.

Join TFS HealthScience Today:

Embark on a rewarding journey with TFS HealthScience and contribute to groundbreaking advancements in healthcare. Apply now to be part of our dynamic team and make a difference in the lives of patients worldwide.