Reports to: Senior Vice President (SVP), Regulatory Affairs
FLSA Status: Exempt
Candidates for Associate Director/Director, Regulatory Affairs will be responsible to provide regulatory leadership to project teams and is responsible for managing regulatory activities for assigned projects. These include leadership in the preparation and compilation of regulatory submissions, managing regulatory submission processes, and timelines, and collaborating with Regulatory Operations to ensure timely submissions. The candidate will be a direct contact for health authority communications and will manage the activities of consultants and/or contractors in the performance of the duties outlined below.
The Associate Director/Director, Regulatory Affairs is responsible to perform the following tasks:
- Work closely with development team members to develop the global regulatory strategy for all cross-functional areas including clinical, preclinical, CMC to meet business objectives
- Manage the creation and maintenance of global regulatory submissions in support of all phases of clinical development
- Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
- Lead efforts for coordinating content for original INDs, IND amendments, CTAs and NDAs
- Work with department management on plans for NDA/ MAA submissions and lead preparation and review
- Take a lead role in preparations for Regulatory Agency meetings including drafting briefing documents
- Participate in multidisciplinary efforts to prepare updates for regulatory documents including: investigator brochures, annual reports, product labeling, CTA and IND amendments, safety submissions
- Work with regulatory organizations and partners to prepare applications and respond to queries to enable maintenance of regulatory submissions outside of the United States
- Establish, manage, and maintain a knowledge base of current and emerging regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues
- Ensure communication and alignment on regulatory strategy through partnership and communication with internal key stakeholders, including representing the regulatory department at strategy meetings
- Assure compliance with regulatory standards and guidance documents
- Prepare, submit, track, index, and archive electronic submissions
- Ensure that changes are reported to authorities in accordance with regulatory requirements
- Conduct regulatory risk assessments of global regulatory issues
- Liaise with Medical Writing, contract CROs, and Regulatory Operations for coordinating and publishing submission documents
- Manage regulatory vendors, and contractors
- Adhere to InCarda Therapeutics, Inc. Employee Handbook
Knowledge, Skill, and Competency Requirements:
- Experience with all stages of the clinical development (IND/ CTA) and registration (NDA/MAA)
- Experience with regulatory health authority interactions in North America and Europe
- Experience with drug-device combination product development is desirable
- Knowledge of the drug development process, drug laws, and global regulations and requirements
- Strong analytical skills, problem-solving ability, and presentation skills required
- Flexibility and ability to prioritize and manage multiple tasks simultaneously
- Demonstrated ability to establish and meet priorities, deadlines, strategic department goals, and objectives
- Experience in departmental budgeting, organizing, and planning
- Excellent collaborative skills, ability to work in a start-up environment, and manage change complexity
- Computer literacy including working knowledge of computer applications such as Word, Excel, and Outlook required
- Ability to organize activities and multitask, be performance-driven, and possess good decision- making skills
- Strong verbal and written communication skills.
- B.S. in a scientific discipline is preferable with a minimum of 8+ years of regulatory affairs experience is required
This position has no current supervisory responsibilities aside from those associated with managing the work of consultants and/or contractors for assigned projects.
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure.
This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
I fully understand this position description and what is expected of me in this role. I have been given the opportunity to ask questions, and they have been answered to my satisfaction.