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Scientific Supplier
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Head of Regulatory Affairs and Compliance
Scientific Supplier
Regulatory & Compliance
Real World Data
Europe & US
£80,000 - £100,000
Pharma/Biotech
Role Requirements
Position Summary:
As our organisation continues to grow we are looking for a Head of Compliance / Regulatory Affairs who will provide worldwide, strategic leadership in and comprehensive understanding of the government regulatory requirements for product development utilizing regulatory knowledge and expertise to ensure regulatory compliance.
Essential functions of the job include but are not limited to:
Regulatory Oversight / Intelligence
Develop and implement strategies for the timely preparation and execution of regulatory documents to regulatory authorities for contracted programs.
Provide expert analysis and evaluation of regulatory information. Informs the teams (internal and external stakeholders, as needed) of the regulatory status of products / programs and significant regulatory issues.
Provides analysis of regulatory guidance documents, regulations or directives that influence Precision’s operations and impacted programs. Advises other departments as well as external stakeholders regarding their applicability and impact.
Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures.
Develop global regulatory strategy(s) for contracted clinical programs to ensure successful initiation, execution and submission for global registration.
Lead and/or facilitate team preparation for regulatory agencies/Health Authority meetings.
Lead and/or facilitate communications with regulatory agencies.
Preparation of briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs/BLAs, and Annual reports
Provide oversight to study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications.
Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, statistical analysis plans and clinical study reports)
Provide guidance and leadership to the members of the Team.
Develop, define and lead internal growth and resourcing strategy for Regulatory Affairs within the organization and direct and oversee all regulatory staff.
Oversee the development and management of the regulatory infrastructure.
Develop and manage a global budget and resourcing supporting the Team.
Lead Regulatory Affairs business development activities.
Contribute to development of regulatory consulting business to support client development and growth, to achieve an initial annual sales target for regulatory-specific work (outside of clinical trial support)
Person Specifications
Qualifications
Minimum Required:
Bachelor’s degree in related discipline.
10+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience. Expert knowledge of all aspects of the drug development process inclusive of regulatory milestones
Significant experience in all aspects of meeting with Regulatory/Health Authorities supporting drug development.
Ability to apply knowledge of FDA, EMA Global Health Authority requirements and ICH guidelines both strategically and operationally and provide direction to resolve complex regulatory issues.
Expertise in preparing complex regulatory documents and other major regulatory submissions.
Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills.
Strong interpersonal and client-facing skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, budgetary responsibility, commitment to highest quality and the requirements of business development and pharmaceutical collaborating are necessary.
Proven ability to communicate with management, external thought-leaders and operational staff.
Ability to guide, train and supervise personnel; oversees the work of direct reports to ensure ontime, on target and within budget results.
Flexible attitude with respect to work assignments, and new learning opportunities
Prior experience in business development activities
Availability for domestic and international travel including overnight stays.
Preferred
Advanced degree
Experience growing and managing a global regulatory function – CRO and Pharma experience preferred.
Prior work experience in haematology/oncology
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Locations
Alabama
Alaska
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Hawaii
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maine
Maryland
Massachusetts
Michigan
Minnesota
Mississippi
Missouri
Montana
Nebraska
Nevada
New Hampshire
New Jersey
Date Updated
20 Sep 2024
Job reference
73198
Categories
Full Time
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