Descripción de la oferta
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.
Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our team.
Essential functions of the job include but are not limited to:
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review 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 marketing applications. Also provides strategic regulatory input as required
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serve as representative of Global Regulatory Affairs at business development meetings
Minimum requirements
Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
Computer literacy (MS Office/ Office 365)
Fluent in English
Preferred qualifications
Graduate, postgraduate
Possesses basic understanding of financial management
Other requirements
Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions.
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel including overnight stays
Competencies
Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
Ability to manage multiple and varied tasks in a fast-moving environment, good record‑keeping skills
Exhibits high self‑motivation, and is able to work and plan independently as well as in a team environment
Motivates other members of the project team to meet timelines and project goals
Flexible attitude with respect to work assignments, and new learning
Resolves project related problems and prioritize workload to meet deadlines with little support from management
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
Collects data of consistently high standard
Communicates effectively in the English language both verbally and in written form
Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
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.
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