Sr. Country Approval Specialist/Principal Country Approval Specialist

Work Schedule

Environmental Conditions

Job Description

Join Us as a Sr. Country Approval Specialist/Principal Country Approval Specialist Make an Impact at the Forefront of Innovation
The Sr. Country Approval Specialist/Principal Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

What You'll Do:

• Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
  • Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
  • Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
  • Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
  • Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
  • Act as a key-contact at country level for all submission-related activities.
  • Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.
  • Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
  • Achieve company’s target cycle times for site activations.
  • Prepare the regulatory compliance review packages, as applicable.
  • Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
  • Develop country specific Patient Information Sheet/Informed Consent form documents.
  • May assist with grant budgets(s) and payment schedules negotiations with sites.
  • Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
  • Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
  • Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
  • Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s.
  • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate
  • Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate.
  
  Education & Experience Requirements:
  • 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- 5+ years).
  
  In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  
  Knowledge, Skills, Abilities:
  • Effective oral and written communication skills
  • Excellent interpersonal skills
  • Strong attention to detail and quality of documentation
  • Good negotiation skills
  • Good computer skills and the ability to learn appropriate software
  • Good English language and grammar skills
  • Good judgment and decision-making skills
  • Basic medical/therapeutic area and medical terminology knowledge
  • Ability to work in a team environment or independently, with minimal supervision, as required
  • Ability to mentor fellow SIA team members in a positive and effective manner
  • Excellent team player with teambuilding skills
  • Basic organizational and planning skills
  • Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations
  
  
  Working Conditions and Environment:
  •Fully work from home position
  
  Why Join Us?
  
  When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
  
  Apply today to help us deliver tomorrow’s breakthroughs.

Originally posted on Himalayas