Job description
Position Overview:
As the Associate Director / Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory requirements.
You will develop and implement US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. You will collaborate closely with cross-functional teams, including Clinical Development, Medical Affairs, Quality Assurance, and Commercial, to achieve regulatory milestones and support successful product development and commercialization.
Reporting Relationship: This position will report to the VP of Regulatory Affairs, Medical Writing & Pharmacovigilance
Essential Duties and Responsibilities:
Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
Additional Qualifications:
As the Associate Director / Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscape and ensuring compliance with regulatory requirements.
You will develop and implement US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. You will collaborate closely with cross-functional teams, including Clinical Development, Medical Affairs, Quality Assurance, and Commercial, to achieve regulatory milestones and support successful product development and commercialization.
Reporting Relationship: This position will report to the VP of Regulatory Affairs, Medical Writing & Pharmacovigilance
Essential Duties and Responsibilities:
Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment.
- Develop and implement global regulatory strategies for rare disease therapeutic programs, ensuring alignment with corporate objectives and regulatory requirements.
- Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
- Provide strategic guidance and leadership to cross-functional teams on regulatory requirements, agency interactions, and submission strategies throughout the product lifecycle.
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, BLAs, NDAs, and other relevant filings, ensuring compliance with applicable regulations and guidelines.
- Monitors the development of new regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs
- Proactively monitor and analyze regulatory trends, guidelines, and developments related to rare disease therapies, and provide strategic recommendations to senior management.
- Serve as the primary point of contact for regulatory agencies (FDA, EMA, etc.), representing the company in interactions, meetings, and negotiations.
- Collaborate with cross-functional teams to develop and execute regulatory communication plans, including scientific advice meetings, pre-submission meetings, and regulatory authority interactions.
- Build and maintain effective relationships with key stakeholders, including regulatory agencies, key opinion leaders, and external consultants.
- Stay current with evolving regulatory requirements and best practices, and ensure compliance with all applicable regulations, guidelines, and industry standards.
- Provide regulatory guidance and support to internal teams to ensure compliance with regulatory obligations throughout the organization.
- Mentor and develop regulatory team members, fostering a culture of excellence, collaboration, and continuous learning.
Additional Qualifications:
- Minimum of 6 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on rare diseases and orphan drug development.
- Strong knowledge of global regulatory requirements and guidelines for drug development and registration, including FDA and EMA regulations.
- Proven track record of successfully leading regulatory strategy and submissions for rare disease therapeutic programs.
- Experience with regulatory interactions, including FDA meetings (pre-IND, end-of-Phase 2, pre-NDA, etc.) and EMA scientific advice procedures.
- Demonstrated ability to provide strategic regulatory guidance and effectively communicate complex regulatory information to cross-functional teams and senior management.
- Strong leadership and people management skills, with the ability to motivate and develop high-performance teams.
- Excellent written and verbal communication skills, with the ability to influence and negotiate with internal and external stakeholders.
- Ability to work effectively in a fast-paced, dynamic environment with a high degree of flexibility and adaptability.