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OPEN POSITIONS

SENIOR CMC/RA CONSULTANT - EU

(Freelance)

Phortas is currently looking for a FREELANCE Senior CMC/RA for the upcoming and ongoing projects.

Experience/Requirements:

  • Defining CMC strategy for drug development projects.

  • Participating as regulatory CMC expert in product development teams.

  • Preparing for and participating in FDA/EMA/national scientific advices.

  • Ability to review and write CMC sections of INDs, IMPDs, NDAs, BLAs, MAAs, and post approval changes, including line extensions, renewals, etc.

  • Strong ability to assess, analyze and interpret CMC source documents and raw data

  • Coordinate and interact with manufacturers of APIs and/or finished products to get required CMC data

  • Coordinate and contribute to responses to Agency queries.

  • Strong working knowledge of eCTD

  • Life science degree 

  • Must have previous freelance CMC experience 

  • Relevant freelance experience in CMC, scientific and technical writing

  • Outstanding command of the English language and communication skills

  • Flexibility and professional conduct

  • Demonstrated leadership and project management skills

 

 

Start date: Q2 2021

Hourly rate: Negotiable

Location: Home-based (Europe)

Please send your CV with a short summary of your experience to careers@phortas.com

Not found what you were looking for?

We are always interested in hearing from talented individuals.

 

If your dream position is not currently available at Phortas, but you are interested in working here, send us your CV and cover letter to careers@phortas.com.

 

Your application will always remain strictly confidential.

Recruiters / Agencies

Phortas does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation, search firms, staffing agencies, fee-based referral services and recruiting agencies. The submission of referrals or resumes by anyone other than a candidate directly to Phortas employees is strictly prohibited. Unsolicited referrals and resumes sent to Phortas are deemed gratuitous, and the company will not be obligated or bound in any way to pay any referral or other fee if a person referred to us from a source other than a candidate is hired.