Description: This individual will play a key role in developing the regulatory affairs department at Surgenex LLC. They will be responsible for regulatory activities as well as overseeing clinical trial(s) in accordance with all applicable regulations governing the conduct of clinical trials. The Sr. regulatory affairs specialist provides operational leadership to ensure project milestones delivery on time, within budget, high quality, and in compliance with applicable regulatory guidelines and all SOPs/Work Instructions (WIs). The applicant should have critical thinking skills for problem solving and have the lateral and strategic thinking capacity to drive the BLA approval process with effective communication across organization.
- Responsible for the development of the BLA regulatory strategy for submissions. These submissions include IND/CTA/BLA and RMAT regulatory filings.
- Lead the preparation and review RMAT/BLA/CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions.
- Interact with regulatory agencies and represent Surgenex at regulatory agency meetings/conferences.
- Responsible for the management of regulatory approval activities related to specific developmental or commercial biologics.
- Responsible for the regulatory evaluation of CMC change controls.
- Represent Regulatory Affairs on cross-functional teams such as product development teams.
- Take a leadership role in the development teams.
- Maintain knowledge of global regulatory environment, regulations and procedures.
- Lead defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines
- Serve as a member of one or more Clinical Operations study teams
- Participate in developing and finalizing cross-functional deliverables such as clinical study protocols, CRFs, consent forms, study reference manuals, study reports, annual reports and other clinical documents
- Review reports or field staff monitoring reports and ensure completion of action items. Identify trends and risks. Escalate unresolved issues.
- Proactively identify issues and risks and propose mitigation strategies
Competencies & Skills:
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced and enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships.
- Proven proficiency in overseeing large complex studies.
- Must have experience with regulatory documents (BLA, FDA responses and IND)
- Experience in the development of regulatory strategy with a focus on BLA, clinical trials, case studies, and biologic marketing applications.
- Thorough knowledge of FDA and HCT/P guidelines.
- Have a solution-oriented approach to problem solving
- Expertise in the biologic drug development process and post approval activities
- Ability to work on complex projects and within cross-functional teams
- Experience with CMC and cGMP regulations for biologics or pharmaceuticals.
- Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues.
- Excellent interpersonal and decision making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives.
- Demonstrated ability to comprehend complex scientific concepts and data.
- Proficient in reviewing and assessing clinical data.
- Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
- Experience in working in a small organization
- Excellent written and oral communication skills.
- Proven ability to successfully plan, implement, and manage regulatory filings
- Strategic thinking skills
- Agility and flexibility
- Occasional travel
- Minimum: BS/BA degree in Scientific Discipline
- A minimum of 5 years in the medical/clinical/pharmaceutical industry, and preferred experience of 3 years regulatory (biologics preferred)
- 3+ years industry experience in clinical drug/biologic post launch activities
- Previous osteoarthritis (OA) experience preferred
Previous RMAT experience preferred
Job Type: Full-time