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Regulatory Affairs Strategist

hace 2 semanas

Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completo
Job Description

We are seeking a highly organized Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific.

Key Responsibilities:
  • Strategic Regulatory Intelligence: Provide innovative regulatory solutions and expertise to support product development from preclinical stages through registration and product optimization.
  • Regulatory Compliance: Ensure that client deliverables meet current local, regional, and ICH regulatory and technical requirements.
  • Liaison and Coordination: Act as a liaison with internal and external clients and oversee the preparation and submission of regulatory documentation.
Essential Functions:
  • Documentation and Submission Support: Assist in the preparation of documentation and submissions under guidance.
  • Client Deliverable Management: Coordinate and manage client deliverables ensuring regulatory compliance.
  • Status Tracking and Adaptation: Liaise with internal and external clients to track and update the status of long-range planning, adapting to changing priorities and handling multiple projects.
  • Independent Judgment and Negotiation: Exhibit good negotiation skills and the capability to work independently with direction, exercising independent judgment.
  • Compliant Deliverables: Independently assess sponsor regulatory needs and collaborate with project team members to produce compliant deliverables.
  • Global Regulatory Knowledge: Possess basic knowledge of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.
  • Medical Terminology and Guidelines: Understand medical terminology, statistical concepts, and guidelines.
  • Analytical and Problem-Solving Skills: Demonstrate good analytical, investigative, and problem-solving skills, with the ability to interpret data.
New Tasks and Responsibilities:
  • Submission Oversight: Accountable and responsible for overseeing all submission types to Regulatory Authorities and/or EC/other local submissions, including North America IRB submissions.
  • Country-Specific Applications: Manage country-specific local applications, overseeing the entire process from preparation to approval.
  • Regulatory Requirements and Follow-up: Collect regulatory requirements and coordinate country-specific local applications, relying on RegView entries and follow-ups with CASs.
  • Standard Procedures Adherence: Ensure adherence to standard RAL procedures applicable to EC and RA submissions.
  • Document Development and Filing: Oversee the development, translation, and filing of country and site-specific submission-related documents for RA, US IRBs, and Canadian ECs submissions.
  • Timeline Adherence and Document Receipt: Ensure that submission-related documents are received within the agreed timeline and filed according to agreed processes.
  • Deadline Communication: Inform all Lead RAL and/or functional leads of the required deadlines for submission document availability.
  • Collaborative Efforts: Liaise with Lead RAL and/or responsible functional leads in the CRG internal team to ensure documents required for submission are ready in time as per the submission plan.
Working Conditions and Environment:
  • Office Environment: Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional Travel: Occasional drives to site locations with occasional travel, both domestic and international.
Physical Requirements:
  • North America IRB Activities: Coordinate all North America IRB activities and ensure that essential document quality meets the expectations of Regulatory Compliance Review.
  • Timely Submissions: Ensure timely North America regulatory and/or IRB submissions and follow up on all questions raised by ethics committees.
Management Role:
  • No Management Responsibility: No management responsibility.

This role requires a highly organized individual with strong regulatory expertise and the ability to manage multiple projects and adapt to changing priorities. The successful candidate will possess excellent communication and negotiation skills, along with a basic understanding of the regulatory landscape and procedures.

Qualifications:

Education and Experience: Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Knowledge, Skills and Abilities:
  • Communication Skills: Good English language (written and oral) communication skills as well as local language where applicable.
  • Attention to Detail: Good attention to detail and quality as well as editorial/proofreading skills.
  • Interpersonal Skills: Good interpersonal skills to work effectively in a team environment.
  • Computer Skills: Good computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies.
  • Organizational and Time Management Skills: Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects.
  • Negotiation Skills: Good negotiation skills.
  • Independence and Judgment: Capable of working independently with direction and exercising independent judgment.
  • Sponsor Regulatory Needs Assessment: Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables.
  • Regulatory Knowledge: Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management.
  • Medical and Statistical Knowledge: Basic understanding of medical terminology, statistical concepts, and guidelines.
  • Analytical Skills: Good analytical, investigative and problem-solving skills.