Regulatory Affairs Consultant - CMC Biologics / Plasma Products at Parexel | chakrie

Requirements

Expertise in CMC regulatory strategy, post-approval regulatory processes, and quality/technical documentation
Experience working in regulatory affairs, pharmaceutical quality, or a highly regulated environment
The ability to collaborate across teams and communicate clearly with internal stakeholders and regulatory authorities
A quality-focused mindset and strong attention to detail in regulatory documentation and compliance
Comfort working with regulatory information management systems, Word, PowerPoint, and Excel
Bachelor’s in Chemistry or a related Life Sciences field of study
5+ years of experience in regulatory affairs, particularly in technical/CMC/quality regulatory roles within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements for global markets (US, EU, CA, CH, AU, CN, BR)
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Previous biologics regulatory CMC experience
Knowledge of plasma product manufacturing processes and regulatory requirements is a plus
Strong communication, organization, and problem-solving skills
Background in validation, Quality Assurance, or production in the pharmaceutical industry with experience in preparing regulatory documentation
Understanding of qualification and validation principles
Experience with Veeva Vault or other regulatory information management systems
Fluency in English and additional languages

Responsibilities

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Skills & expertise

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

Everything else on this page, kept up to date and available to every member of Chakrie at no cost at all.

Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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