Senior Regulatory Affairs Associate / Consultant - CMC Biologics

Excellent opportunity for an experienced CMC Biologics Regulatory Affairs professional to bring your talent, excellent communication skills, strong regulatory writing experience, and CMC expertise to Parexel Consulting as a Senior Regulatory Affairs Associate / Consultant!  

In this highly visible role as a Senior Regulatory Affairs Associate / Consultant role, you will gain tremendous exposure to novel technologies while partnering closely with a large multinational pharmaceutical company and supporting the regulatory submission activities for the various biologic products in development.

The Technical Regulatory Writer is involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions.

-Write CMC, “facility and equipment” parts and new files for WW regulatory File.

· Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion.

· Ensure the coordination with the departments involved in the writing/review process

· Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities

· Monitor that supportive data provided by other departments are compliant.

· Report significant issues

· Manage the projects within all client tracking tools

· Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.

Knowledge/skills:

· Knowledge of regulatory procedures / systems / guidances

· Good level of spoken and written English

· Good level of spoken and written local language

· Knowledge of biologic process and process equipment.

· Knowledge of Qualification / Validation principles

Soft skills:

· Manages own time to meet agreed short-term targets

· Good communication skills

· Writing skills

· Analytical skills, creative and critical mind

· Ensures the coherence between contributions / quality of final results

· Team player

Experience:

· Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).

· Experience working in validation/QA/production in Biologics/Pharmaceuticals industry

Required:

- Minimum of a BA/BS in Life Science; graduate degree preferred

- 2-5 years pharmaceutical/biotechnology experience related analytical/pharmaceutical chemistry and/or regulatory affairs

- Previous experience with development CMC biologics experience.  Additional vaccines related development experience is a plus, but not required

- Demonstrated expertise in writing/developing CMC documents (Module 2 and Module 3) in support of global regulatory submissions

- Experience in submitting and supporting US, Canadian, and European regulatory filings.

- Experience with ICH and electronic submission guidelines for regulatory reports.

- Excellent written and verbal skills

- Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization

- Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies preferred

- Ability to function in an ambiguous environment 

This role may require <15% travel to client location in the future as needed

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

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