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Regulatory Affairs Manager / Senior Manager

Regulatory | Waltham, MA | Full Time

Job Description

About Oncopeptides:

 Oncopeptides is a global biotech company committed to developing targeted therapies for patients facing hard-to-treat hematological diseases. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. PEPAXTO is approved for patients with triple-class refractory multiple myeloma and was evaluated in several clinical studies including the pivotal Phase 2 HORIZON study and is currently being evaluated in the confirmatory Phase 3 OCEAN study. Oncopeptides’ headquarters is in Stockholm, Sweden, with a U.S. headquarters in Boston, Massachusetts. In addition to Boston, Oncopeptides has a footprint in Los Altos, California, another U.S. biotech hub.  PEPAXTO®is a trademark of Oncopeptides AB (publ).

The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.

The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com


Position:  

The Regulatory Affairs Manager / Senior Manager will be participating in multiple Regulatory Affairs operational activities at Oncopeptides. It is a U.S.-based function but also includes work related to regulatory submissions world-wide. The work is performed in close collaboration with the Head of Regulatory Affairs (based in Sweden) and may develop over time depending on needs, competence and interest.

This position is based in Waltham, MA.  


Key responsibilities include, but are not limited to:

  • Support U.S. business team with IND and NDA submissions and regulatory input

  • Coordinate, contribute to and review documents for regulatory submissions including documents for IND/NDA/MAA

    • CMC, nonclinical and clinical materials

    • Investigational and post-approval

    • Promotional material review

  • Participate in planning of regulatory activities

  • Participate in the development of regulatory strategies

  • Plan and participate in meetings with regulatory agencies

  • Preparation and archiving of regulatory documentation

  • Maintain knowledge of U.S. regulatory requirements (format and content)

  • Participate in process improvement initiatives and development of SOPs as applicable.

 

Ideal Experience:

  • Relevant university degree (e.g. BS), preferably in a science-related field

  • Regulatory affairs experience:

    • 5 years or more in a regulatory affairs role

    • Understanding of drug development and post-approval regulatory requirements

    • eCTD submission experience

  • Excellent verbal, writing and computer skills

  • Excellent organizing ability

  • Attention to detail

  • Proven track record of working independently and in teams





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