Sr Director, Regulatory Affairs
The Sr Director, Regulatory Affairs is responsible for directing the Company's global regulatory strategies. This role establishes the organization's goals and objectives regarding regulatory affairs and ensures they are achieved. This individual is responsible for leading all submissions and communications with regulatory authorities and managing international submissions and responses.
This individual has the overall responsibility for managing required resources and meeting an aggressive regulatory submission schedule necessary to ensure the effective fulfillment of goals and objectives. The Sr Director, Regulatory Affairs will partner with key stakeholders to ensure they are aligned with the regulatory strategy.
- Manages the preparation and reviews submissions to the FDA and other global health authorities.
- Manages international regulatory submission requirements, including the day-to-day responsibilities of regulatory submissions.
- Provides guidance and recommendations to key stakeholders within the organization and monitors compliance with regulatory requirements and commitments.
- Coordinates responses and interactions between the company and regulatory agencies on matters relating to Harpoon product regulatory submissions.
- Maintains up-to-date knowledge and understanding of regulatory requirements and concerns that affect the company and communicates changes to relevant personnel.
- Provides guidance and oversight for any product complaints and regulatory reporting.
- Keeps leadership apprised on the status, objectives, risks and mitigation plans associated with the various internal projects, as well as ensures regulatory teams are aware of current integrated program timelines.
- Remains current with regulatory intelligence and ensures submissions are aligned with current standards/expectations.
- Demonstrates expert knowledge of submission or technology-related global Health authority guidelines/regulations.
- Act as primary regulatory contact and strategist with the FDA, international regulatory agencies and other regulatory bodies.
- Provide regulatory oversight for product development, manufacturing and product expiry/retest.
- Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally.
- Monitor the US and international regulatory environments and provide Senior Management with assessments of the impact of new and changing regulations on the company’s business.
- Develop and implement training programs for direct reports and other functional groups to assure awareness of all requirements and maintain compliance with all current regulation.
- Coordinate the review and approval of product labeling
- Identify issues early in the submission process that could potentially impact product development
- Determine submission requirements and coordinate plans and timelines with Project Management
- Evaluate risks and safety issues and recommend regulatory solutions during the clinical phase
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approvals
- Organize, prepare and review FDA applications and other regulatory documents, including clinical study protocols/data and CMC.
- Monitors regulatory outcomes and provides input and advice to Senior Management Team
- Leads organization through regulatory due diligence
- Keeps ahead of domestic and international regulatory requirements and changes within the regulatory registration processes. Advises management on future domestic and international regulations.
- 15+ years experience in Pharmaceutical Regulatory Affairs
- Five to ten years' experience in managing personnel and complex activities.
- PharmD or PhD preferred; Bachelor’s degree required
- Proven ability in leading and directing regulatory affairs,
- Oncology experience desirable
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- Excellent communication, analytical and organizational skills.
- Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations and mentality of the FDA and other health authorities.
- Experience working with regulatory processes; particularly those employed in North America and Europe
Harpoon anticipates that the annual base salary for this position could range from between $235,000.00 - $270,000.00 and will depend, in part, on the successful candidate’s credentials for the role, including education, qualifications, and type as well as length of experience. Any offered salary is also based on internal equity, internal salary ranges, market data, and the position’s wage range. The salary range listed does not include any applicable bonuses or long-term incentives, differential pay or other forms of compensation or benefits. Harpoon is a multistate employer and the salary offered will be market competitive. At Harpoon, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case.