Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
The Director Regulatory Affairs will provide leadership of teams responsible for regulatory submissions worldwide. The Director Regulatory Affairs will provide regulatory strategy and support for all regulatory and ethics submission in relation to Clinical Trials and drug development including Health Authority interaction, attending meetings, and provision of strategic regulatory support to other departments, project teams, and committees. The Director Regulatory Affairs will support the development of the Regulatory department and enhance corporate Regulatory functions and facilitate business development and proposals in this area.
Essential functions of the job include but are not limited to:
- Provide strategic, technical, and regulatory guidance to clients and team members in the area of clinical development of human medicinal products and drug development life cycle
- Establish operational objectives and assignments for assigned team members
- Track and report regulatory function metrics and key performance indicators
- Oversee, review and provide strategic input on applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and expedited pathways
- As needed, review documents intended for submission to the Regulatory Authorities and/or Ethics Committees to ensure compliance with regulatory standards
- Select, train, develop, coach and manage the performance of Regulatory Managers, ensuring the sharing of best practices across the team
- Oversee resource allocation and utilization of Regulatory Managers
- As needed, represent Global Regulatory Affairs at project team meetings with both external and internal customers and manage/oversee regulatory workflow between departments
- Provide oversight to filing and study teams regarding regulations/guidelines and company SOPs to ensure successful and high-quality regulatory applications
- Ensure budgets and plans meet corporate requirements
- Provide ICH/GCP/Regulation guidance, advice and training to internal and external clients
- Participate in developing, implementing, and maintaining the corporate quality initiatives across business units within Clinical Solutions/Precision for Medicine
- Implement regulatory tools to support the department
- Assist in developing, modifying and executing company policies that affect Regulatory Affairs and may impact other departments
- Support QA audits and/or assign applicable team members to participate in audits
- Establishes and maintains a high level of technical knowledge in the area of product development and international regulatory affairs. Interprets emerging regulatory requirements and collaborates in impact assessment and implementation
- Supports Business Development in generation of customer focused, well-presented regulatory proposal content and budgets, partnering with other functional areas as required to define bid content, strategy, scope of work
Qualifications:
- Post Graduate Degree, Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- 10+ years or more relevant regulatory affairs experience in CRO, Pharma, Biotech or related industry
- Extensive and broad knowledge and experience of all aspects of drug development process, including subject matter expertise in regulations and guidelines (including but not limited to: NA, EMA, APAC, national authorities and IHC/GCP/GMP)
- Proven track record of supporting client development activities leading regulatory pharmaceutical product development and managing complex regulatory clinical programs
- Previous line management experience
- Computer literacy (MS Office/ Office 365)
- Fluent in English
Preferred:
- Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC (or equivalent) certification/Masters in Regulatory Sciences
- Experience in functional management including experience in delegating while fostering cohesive team dynamics
- Possesses understanding of financial management
Other Required:
- Expert knowledge of all aspects of the drug development process inclusive of regulatory milestones
- Exhibits advanced specialized knowledge of regulatory activities in at least one major region (EU/US/APAC) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
- Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
- Specialized knowledge of regulatory activities including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, ODDs and PIPs.
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
- Expert knowledge of clinical trials methodology, including a knowledge of protocols and indications being studied
- In-depth knowledge and expertise with relevant global regulations and guidelines supporting clinical pharmaceutical development ((includes but not limited to FDA, EMA, other international regulations and ICH-GCP guidelines) and the ability to communicate such to internal and external clientsAble to understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
- Ability to guide, train, and supervise personnel; oversee the work of direct reports to ensure on-time, on-target and within-budget results
- Availability for domestic and international travel including overnight stays
Competencies:
- Excellent presentation, verbal and written communicator with strong interpersonal skills.
- Ability to manage multiple and varied tasks in a fast-paced environment while excellent record keeping skills.
- Ability to work on significant complex issues where analysis of situations or data requires an evaluation of intangibles
- Foster a culture of mutual respect and collaboration
- Ability to change the thinking of or gain acceptance of others in sensitive situations
- Ability to prepare and conduct presentations of a technical nature to senior management within functional area
- Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency
- High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective
- Makes decisions based on resource availability and functional objectives
- Ability to exercise independent judgement and manage ambiguity
- Ability to prioritize and delegate tasks
- Ability to coordinate, manage and supervise multiple projects
- Results oriented, accountable, motivated and flexible
- Proven ability to communicate with senior management, external thought-leaders and operational staff
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We invite you to learn more about our growing organization serving our clients that are researching ground breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company.
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