Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

The Senior/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:

For Senior Country Approval Specialist:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (2+ years direct startup experience in CRO/Sponsor setting or comparable to 5+ years relevant experience).

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.

For Principal Country Approval Specialist:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (5+ years direct startup experience in CRO/Sponsor setting or comparable to 8+ years relevant experience).

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