Senior Director, Regulatory Affairs
4 months ago
ESSENTIAL DUTIES & RESPONSIBILITIES:
- Provide regulatory strategies, tactical guidance, information, training, support and overall corporate/strategic planning based on applicable regulations and guidance issued by the applicable regulatory agency(ies).
- Ensure project team and key stakeholders are apprised of developments that may impact regulatory success.
- Proactively anticipate risks and be responsible for developing solutions to identified risks and discussing with key stakeholders; understand probability of technical success for the solutions.
- Lead submission types such as INDs, NDAs, BLAs, meeting requests with underlying information to FDA and other health authorities
- Direct point of contact with FDA (and other health authorities as warranted), lead and manage FDA meetings and work with all relevant parties to successful outcomes. • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Lead regulatory agency interactions, communications, and submissions, including assembly and submission of applications to competent authorities.
- Partner with global market access/commercial colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as warranted.
- Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
- Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical development programs to ensure compliance with regulations and guidelines.
- Develop Regulatory Document Management Plan and review all regulatory documents needed for study (site) initiations and track overall status
- Draft and review applicable SOPs
EDUCATION AND/OR EXPERIENCE:
- BA/BS; advanced degree preferred.
- Must have strong experience in hematology/oncology regulatory affairs. • Minimum 8 years of experience in clinical R&D and/or clinical research organizations focused on regulatory affairs with expertise from IND-submission to post-approval Phase 4 studies.
- Extensive knowledge of clinical and product development life cycles for investigational and marketed health care products.
- Extensive working knowledge of activities related to regulatory affairs, reimbursement and quality assurance, both domestic and international.
- Experience in authoring, reviewing and submitting all key components of regulatory submissions (orphan, fast track, breakthrough, NDA, BLA, etc).
- Comprehensive knowledge of ICH-Good Clinical Practice (GCP), GMP, Quality Systems Management (ISO 13485).
- Strong understanding and interpretation of complex scientific issues across multiple programs as it relates to regulatory requirements and strategy for assigned programs and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
OTHER SKILLS & ABILITIES:
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Demonstrated high energy level.
- Ability to handle multiple tasks and challenges simultaneously.
- Demonstrated ability to form strong working relationships across functional boundaries. • Excellent written and verbal communication skills.
- Excellent negotiation skills.
- Exceptional ability to conceptualize, develop and manage timelines.
- Ability and willingness to travel internationally.