Senior/Principal - Country Approval Specialist

This is a remote regulatory affairs role for a Senior or Principal Country Approval Specialist. You will manage the preparation, review and coordination of Country Submissions in line with global submission strategy. The position is full time, based in North Carolina, United States, and the work schedule is standard Monday to Friday.

What you will do

• Prepare, review and coordinate local regulatory submissions (MoH, EC, and additional special national local applications where applicable, such as gene therapy approvals, viral safety dossiers and import licenses) in alignment with global submission strategy.
• Provide local regulatory strategy advice (MoH and/or EC) to internal clients.
• Develop and implement local submission strategy, and provide technical expertise and coordination oversight for projects with relevant internal departments.
• Serve as primary contact for investigators and with local regulatory authorities, working with the local regulatory manager on complex issues, to ensure submissions are managed in a timely manner.
• Follow guidelines and processes for internal team communications and communications with investigators and country regulatory authorities.
• Act as a key contact at country level for all submission-related activities.
• Take part in Submission Team Meetings, Review Meetings and Project Team meetings as required.
• Coordinate with internal functional departments so site start-up activities align with submissions activities and agreed timelines, and so the submission process for sites and studies aligns to the critical path for site activation.
• Achieve the company's target cycle times for site activations.
• Prepare regulatory compliance review packages, as applicable.
• Liaise within SIA locally to ensure local submission activity is planned and delivered in line with global project submission strategy.
• Develop country specific Patient Information Sheet and Informed Consent form documents.
• May assist with grant budgets and payment schedule negotiations with sites.
• Help identify local out-of-scope activities in a contract in a timely manner and advise relevant functions.
• Support coordination of feasibility activities as required, within agreed timelines.
• Keep trial status information relating to SIA activities accurate and current in the database.
• Oversee country study files and ensure they meet PPD WPD's or client SOPs.
• Maintain knowledge of PPD SOPs, client SOPs and directives, and current regulatory guidelines applicable to the services provided.
• Direct or mentor other SIA individuals assigned to support projects of responsibility, as appropriate.
• Proactively identify issues or anomalies in the regulatory process of a study, and resolve or escalate as appropriate.

What they are looking for

For the Senior Country Approval Specialist level:

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience that provides the knowledge, skills and abilities to perform the job: 2+ years direct startup experience in a CRO or sponsor setting, or comparable to 5+ years relevant experience.

For the Principal Country Approval Specialist level:

• Bachelor's degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience that provides the knowledge, skills and abilities to perform the job: 5+ years direct startup experience in a CRO or 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 and 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 and national country regulatory guidelines and EC regulations.

Other details

Environmental conditions: office. Work schedule: standard, Monday to Friday. The role is remote, located in North Carolina, United States of America, and is full time.

This job is curated by Lifelancer, a talent-hiring platform in life sciences, pharma and IT that connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains. The original posting appeared on Himalayas.