Regulatory Affairs Associate - CMC biologics or vaccines

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At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From reputed company to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do.

reputed company 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 reputed company? 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 reputed company 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 reputed company Vault

- Collaborate with various stakeholders, attending regular calls and meetings

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

- Ensure project team delivers high-reputed company work meeting reputed company expectations and timelines

- Manage project financials and identify new business opportunities

- Deliver consulting services reputed company your area of expertise

- Maintain reputed company 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.