Lead the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia.
- With minimal supervision provide strategic and operational input, guidance and oversight to global project teams to assure that regulatory submissions and all aspects of regulatory compliance support Sumitomo Dainippon Pharma Oncology's R&D objectives.
- Develop and create regulatory strategies for multiple clinical development projects from early to late-stage clinical development.
- Coordinate all aspects of the preparation, review and submission of regulatory documents. This includes the clinical and non-clinical portions of documents.
- Represent the Regulatory Affairs Department as a member of cross functional project teams and provide guidance relating to changing global regulatory requirements.
- Serve as the Company’s Regulatory Affairs Lead in interactions with global health authorities including the FDA, EMA, MHRA, Health Canada and ROW with respect to clinical submission documents.
- Provide leadership and direction in the development of clinical regulatory documents including INDs, CTAs, BLAs, DMFs, PMAs/510(K)s, NDAs and MAAs.
- Make submissions to global regulatory authorities, as required, and maintain an ongoing interactive relationship regarding these submissions.
- Coordinate and maintain reporting schedules for regulatory applications.
- Assure that all aspects of the Company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
- Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.
- Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies.
- Mentor and help develop the strategic & technical expertise of regulatory colleagues who are involved in supporting filings.
- Other duties as assigned.
- Bachelor’s degree in a relevant scientific discipline. Master’s or an advanced degree (PhD, PharmD) is preferred.
- 8-10 years of regulatory affairs experience in the pharmaceutical industry.
- Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements.
- Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC). Experience with development of regulatory strategies in oncology is preferred.
- Strong written and oral communication skills and the ability to interact effectively with project teams.
- Ability to manage regulatory affairs activities and provide leadership in a “hands-on fashion” while utilizing a strategic approach in all aspects of global compliance.
- Other duties as assigned.
Job Location: Cambridge, MA
Equal Opportunity Employer
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