Regulatory Affairs Manager / Senior Manager
Regulatory | Waltham, MA | Full Time
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
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.
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