Senior Director / Executive Director / VP, Regulatory Affairs
Precision for Medicine
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.
As our organisation continues to grow we are looking for a Vice President, 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)
- Lead and facilitate development of any USPI/SmPC labeling activities with cross functional teams for planned regulatory submission. Department Oversight / Leadership
- Provide guidance and leadership to the members of the Regulatory Affairs department.
- 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 Regulatory Affairs department.
- Hire, mentor, and support the personal and professional development of regulatory staff.
- 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)
- Bachelor’s degree in life sciences or medicine
- 15+ years relevant regulatory and/or clinical development pharmaceutical/biotechnology experience Mastery 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.
- Prior experience in developing successful global development strategies of cutting edge and unique therapies.
- Expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA/BLA, Scientific Advice), NDAs/BLAs, and other major regulatory submission.
- Prior experience in business development activities
- Availability for domestic and international travel including overnight stays.
- Advanced degree
- Experience growing and managing a global regulatory function – CRO and Pharma experience preferred.
- Prior work experience in haematology/oncology
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for global regulatory positions and strategy.
- 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
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.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC