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Senior Regulatory Affairs Associate CMC (plasma products) Job Opening In Budapest – Now Hiring Parexel


Job description

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

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 Associate to join our growing team!

As a Senior Regulatory Affairs Associate 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 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 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

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

- Proficiency in Module 1 and 3 writing for plasma products

- 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.

Required Skill Profession

Business Operations Specialists


  • Job Details

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Are You Looking for Senior Regulatory Affairs Associate CMC (plasma products) Job?

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The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Parexel adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying Hungary laws and regulations

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Parexel interview tips for Senior Regulatory Affairs Associate CMC (plasma products)

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