Regulatory Affairs Consultant CMC small molecules

2 weeks ago

RomaniaBucharestMetropolis Center, Romania Parexel Full time 20,000 - 40,000 per year

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all 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 what we do.

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

Are you passionate about regulatory affairs in the life science industry? Do you thrive in a dynamic team environment and enjoy managing complex projects? Parexel is seeking a talented (Senior) Regulatory Affairs Consultant with CMC writing background (small molecule) to join our growing team

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

The role can be office or home based.

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 Lead for small-scale projects or Work Stream Lead 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 within 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

- Solid regulatory experience in EU, other non-EU markets preferred

- Proficiency in Module 1 and 3 writing

- 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 continuous learning and self-development

- Fluent in English, written and spoken

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