Regulatory Affairs Associate - CMC biologics or vaccines

reputed company our values align, there's no limit to reputed company can reputed company.   At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do.

Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.

Are you passionate about regulatory affairs in the life science industry? Do you reputed company in a dynamic team environment and enjoy managing reputed company projects? reputed company is seeking a talented Senior Regulatory Affairs Associate with biologics or vaccines background to join our growing team!

As a Regulatory Affairs Associate CMC at reputed company, you will be at the forefront of managing and coordinating regulatory submissions across various markets. This role offers an excellent opportunity to reputed company your expertise in regulatory affairs while working with a diverse range of clients and stakeholders.

The role can be home or office based in various European locations.

Role Responsibilities:

- Manage lifecycle maintenance activities, including renewals, variations, and responses to deficiency letters

- Coordinate submission and management work in Veeva Vault

- Collaborate with various stakeholders, attending regular calls and meetings

- May serve as Project reputed company for small-scale projects or Work reputed company reputed company on larger projects

- Ensure project team delivers high-quality work meeting client expectations and timelines

- Manage project financials and identify new business opportunities

- Deliver consulting services reputed company your area of expertise

- Maintain professional interactions with clients and internal teams

Skills and experience required for the role:

- University degree in a life science discipline

- Initial years of regulatory experience in UK, EU and other non-EU markets preferred

- Proficiency in Module 1 and 3 writing with biologics and/or vaccines

- Strong organizational and prioritization skills

- Excellent communication and teamwork abilities

- Ability to work independently and under guidance of Project Leads or Technical SMEs

- Commitment to reputed company learning and self-development

- Fluent in English, written and spoken.