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AbbVie Boston, United StatesThe Associate Director, RA Global Regulatory Strategy, US & Canada (Oncology) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products i Director, Strategy, Regulator ...
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DirectorSr Director Regulatory Strategy - Boston, United States - Precision Life Sciences
Description
Position:
Director/Senior Director of Regulatory Strategy
Job Summary:
As a Director/Senior Director of Regulatory Strategy, you will play a critical role in navigating the intricate world of oncology-focused regulatory affairs.
You will work closely with cross-functional teams to develop, implement, and oversee regulatory strategies that align with our mission of advancing innovative oncology treatments.
Key Responsibilities:
Oncology Regulatory Strategy Development:
Develop and execute regulatory strategies specifically tailored to the unique challenges and opportunities in oncology drug development.
Stay abreast of evolving oncology-specific regulatory guidelines and adapt strategies accordingly.
Compliance Oversight:
Ensure oncology drug candidates comply with all relevant oncology-specific regulatory requirements.
Monitor and interpret oncology-related regulations, guidelines, and standards.
Team Leadership:
Manage and lead a team of regulatory professionals specialized in oncology.
Provide mentorship, guidance, and performance management to support the company's mission in the field of oncology.
Oncology Stakeholder Engagement:
Cultivate and maintain relationships with oncology-specific regulatory agencies, key opinion leaders, and industry associations.
Represent the company's interests in the oncology regulatory space and stay informed about oncology-specific regulatory changes.
Oncology Regulatory Submissions:
Oversee the preparation, submission, and maintenance of regulatory documents for oncology drug candidates.
Ensure the accuracy, quality, and timely delivery of oncology-related submissions, such as INDs, NDAs, BLAs, and variations.
Oncology Regulatory Intelligence:
Monitor and assess the impact of oncology-specific regulatory changes on the company's oncology portfolio.
Provide recommendations to address potential oncology-specific regulatory risks or opportunities.
Cross-functional Collaboration in Oncology:
Collaborate closely with research and development, clinical, and quality assurance teams.
Integrate oncology-specific regulatory requirements into the development of innovative oncology treatments.
Oncology Risk Assessment:
Identify potential regulatory risks unique to oncology drug development.
Develop strategies to mitigate these risks, ensuring the efficient advancement of oncology products through the regulatory pathway.
Oncology Regulatory Training:
Develop and implement oncology-specific training programs for employees.
Ensure that employees understand and comply with oncology-specific regulatory requirements to support oncology mission.
Budget Management:
Effectively manage the regulatory budget specifically allocated to oncology activities.
Optimize resource allocation to support oncology regulatory efforts.
Oncology Regulatory Documentation:
Oversee the creation and maintenance of oncology-specific regulatory documents.
Ensure completeness and accuracy of oncology regulatory dossiers, submissions, and technical files.
Oncology Regulatory Audits and Inspections:
Prepare the company for regulatory audits and inspections specific to oncology drug development.
Address findings and implement corrective actions to support objectives.
Qualifications:
A bachelor's or advanced degree in a relevant field (e.g., life sciences, pharmacy, regulatory affairs).
8-10 years of regulatory affairs experience in a senior leadership role, with a proven track record of oncology-specific regulatory strategy development and execution.
In-depth knowledge of oncology-specific regulatory requirements, guidelines, and standards.Strong leadership and team management skills, particularly in an oncology context.
Excellent communication and negotiation skills.
Collaborative mindset, analytical thinking, and problem-solving skills.
Project management and budget management experience.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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