Head of Regulatory Affairs

Lexington, MA
Regulatory Affairs
Full-time
Head of Regulatory Affairs

Curis is seeking a Head of Regulatory Affairs to lead both the Regulatory and Quality functions for Curis.  This role will be essential to the registration and maintenance of the Curis pipeline across the U.S. and Internationally. The Head of Regulatory Affairs will be supported by additional regulatory consultants as needed, based on the ebb and flow of the workload.  


Duties & Responsibilities:

    • Provide strategic regulatory input to the business
    • Responsible for the coordination, preparation and review of regulatory submissions (US and EU/ROW) in support of clinical trials
    • Develop and manage timelines for the preparation of submissions
    • Represent Regulatory Affairs with various internal departments to manage activities and coordinate in the preparation of regulatory submissions
    • Ensure compliance with existing regulatory applications (e.g., IND maintenance including submission of Safety Reports, investigator documentation and Annual Reports)
    • Participate in  team meetings to assure cross-functional coordination
    • Assist with the research, writing and implementation of effective regulatory strategies for global product development, and effectively communicate options, solutions and risks to development team
    • Communicate with regulatory authorities (FDA, EMEA, HC, etc.), as needed
    • Be knowledgeable of key global guidance documents, regulations, or directives and effectively communicate any impact on Curis's development programs
    • Access submission data and regulatory intelligence from available sources and publicly available databases/websites and design the regulatory filing strategy output
    • Manage labelling changes, safety updates, artwork development and artwork approval of packaging material components
    • Build effective working relationships with the regulatory agency and follow-up closely on approvals of product registration and variations.
    • Develop annual regulatory budget
    • Quality Assurance
    • Maintain local quality management system
    • Creation, implementation, training and monitoring of SOPs  based on Curis’s requirements and local regulations
    • Coordinate Quality agreements with external partners for GDP functions
    • Processing of product quality complaints.
    • Responsible for updating the competent authority on any product recalls, withdrawal or defects and any other safety issues.
    • Pharmacovigilance
    • Awareness of the structure and performance of Curis’s pharmacovigilance system
    • Ensure timely submission of safety reports to the competent authorities where requested
    • Accountable for timely conveyance of local safety reports to the competent authority based on the local guidelines

Qualifications

    • Minimum BA/BS, preferably in a scientific discipline
    • Minimum 7-10 years of regulatory affairs experience
    • Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs, NDA/BLA/MAA)
    • Knowledge and understanding of applicable global regulations, guidance documents and regulatory pathways
    • Knowledge of eCTD content/format requirements. 
    • Ability to generate development options and present risk/benefit analyses in order to collaborate and influence cross functional teams
    • Ability to work both independently with direction and within project teams
    • Excellent verbal and written communication skills are essential
    • Strong organizational skills, including the ability to prioritize workload
    • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
    • Must be highly skilled in the use of MS Word, MS Project and spreadsheet programs to prepare outlines, summaries, status reports, templates and slides for distribution and communication.
    • Ability and willingness to travel up to 35% of the time (international and domestic)

No phone calls please.

Curis is an Equal Opportunity Employer committed to a diverse, inclusive workplace. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, pregnancy, genetic information or any other basis protected by federal, state or local law.