Work Schedule

Environmental Conditions

Job Description

• Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

• Prepares, review and coordinates local regulatory submissions (EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develops and implements local submission strategy. Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves 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.
• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• Acts as a key-contact at country level for all submission-related activities.
• Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings.
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieves Client’s target cycle times for site activations.
• Prepares the regulatory compliance review packages, as applicable.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
 

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 1+ years).

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
• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC  regulation