Regulatory Affairs Project Manager

The group exists to provide professional consulting, implementation and project management services to clients to enable the conduct of clinical trials and associated regulatory activities. The group is also responsible to internal customers to inform the design, development, sale, support and implementation of clinical research software as complete solutions or as part of solutions.

The Regulatory Affairs Project Manager will act as key advisor on complex clinical development projects, responsible for the preparation and management of regulatory dossiers in accordance with regulatory requirements.

Key Responsibilities

• Acts as a Regulatory Advisor on complex clinical trial projects or programs.


• Ability to administratively and technically/scientifically review core scientific documentation and feedback gap analysis to customers.


• Prepares and maintains core clinical trial dossiers in accordance with applicable regulatory requirements.


• Ability to write scientific documents e.g. Investigational Medicinal Product Dossier, Investigator's Brochure, clinical trial justifications with minimum support of senior staff;


• Interacts with internal and external clients to provide regulatory guidance and strategic input for clinical development programs.


• May strategically plan and oversee global country submissions.


• Can provide support on regulatory business development opportunities.


• Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.


• Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or Anova).


• Deliver regulatory training/presentations as required.


• Manage, or be responsible for, the global regulatory activities for one or multiple projects/teams and respond readily to changing events and priorities.


• Responsible for the strategy development and creation of regulatory submission documents from early phase regulatory submissions through to marketing applications and post approval activities.


• Understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new biopharmaceutical products, to expedite submission, review and approval of global submissions.


• Work in cross-functional matrix project teams, which include colleagues from regulatory, biopharmaceutical development and medical affairs.


• Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.


• Independently authors complex regulatory documents compliant with relevant internal processes and standards as well as external regulatory guidance. Demonstrates subject matter expertise.


• Provides strategic and operational leadership to direct preparation and completion of documents. Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.


• Drives decision making about data presentation strategies to support and advance planning of documents. Contributes to the development of asset- or therapeutic area-level conventions.


• Develops and maintains project timelines. Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.


• Communicates position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.


• Aligns with department management to set strategy for meeting department goals.


• Identifies potential areas for process improvements and possible solutions and communicates these to line management or appropriate functional line. Leads process improvement initiatives across regulatory affairs activities and may lead cross-functional initiatives to support operational efficiency, quality, and innovation.


• If leading a team of other writers, coordinates efforts of all writers to achieve timely delivery of high-quality, fit-for-purpose documents to the project team.


• If assigned by manager, serves as the Regulatory 'point of contact' for all document issues for a given asset or set of assets.


• Produces documents in conjunction with vendors and clients. Reviews documents produced by vendors and clients and helps evaluate performance and quality.


• Support and participate in other activities of other divisions in the Regulatory Affairs department as applicable.


• Lead by example and model core values in all actions; ensure a positive, respectful team environment, fostering collaboration and development.


• Demonstrate thought leadership and deep regulatory and clinical research expertise.


• Ensure your deep regulatory and clinical research experience influences the planning and delivery of Anova solutions and services to clients.


• Understand key industry trends that drive the need for major customer change.


• Maintain heightened awareness of current and predicted market trends and developments in clinical research regulation.


• Lead, coach and provide guidance and mentoring to Anova colleagues.Foster a culture of excellence, collaboration and continuous learning.

Education

• Bachelor’s degree, preferably in a related discipline such as pharmacy, biotechnology, chemistry or a related science discipline.

Experience

• Thorough understanding of regulatory affairs or biopharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development, through to early life cycle submissions.


• Three or more years’ experience working with worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.


• Three or more years’ experience related to the development and implementation of regulatory strategies and evaluate the potential impact of them on overall project/product strategy.


• Understanding of the role of each member of cross -functional team.


• Ability to collaborate successfully with all levels and roles in cross-functional, global teams.


• Ability to manage documents of greater complexity and/or variety.


• Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.


• Adapts to change as needed.


• Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.


• Ability to identify complex problems that require management or cross-functional input for resolution in timely manner.


• Develops innovative options or multiple solutions to resolve complex problems that impact project completion and/or document content strategy. Demonstrates critical and rapid decision-making.


• Proven experience in a project management role, leading a team or function.


• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.


• Ability to lead cross-functional peers across therapeutic areas for improving a process, not limited to CMC regulatory affairs.


• Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function.


• Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact regulatory affairs.


• Serves as an authority on global regulatory guidance (especially ICH, FDA, and EMA) relevant to quality.


• Advises team on interpretation of global regulatory guidance (especially ICH, FDA, and EMA) relevant to quality.


• Comprehensive understanding of the drug development process and how quality documents support development at different stages.


• Advanced understanding of quality concepts.


• Analytic skills. Ability to examine data and formulate reasonable hypotheses.


• Oral presentation skills. Strong oral presentation skills, including ability to present and explain data analyses.


• Language skills. High fluency in spoken and written English.


• Knowledge of how to use publicly available databases (e g , PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.


• Able to consolidate, analyze, interpret, and summarize data from multiple data sources, with no supervision.


• Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, without guidance.


• Track record of communicating complex information and analyses effectively in writing to a variety of scientific and non-scientific audiences.


• Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (e.g., PowerPoint, Excel).