International Zone Regulatory Affairs Specialist
|Responsibilities and Key Duties:|
· Maintains awareness of international regulatory practices, procedures and changes, as appropriate by project. Assesses impact of the changing regulatory environment to the project, and advises regulatory colleagues and project team members, as appropriate, regarding potential course(s) of action
· Proactively works on the implementation of compliance with current international regulations (VICH, OIE, SRA, etc.)
· Actively participating (directly or indirectly) in the development of new legislation, guidelines or standards
· Utilizing expert technical regulatory skills to influence regulatory authorities on complex issues
· Interacting with regulatory authorities in a persuasive manner for their understanding and acceptance of proposed regulatory approaches
· Taking initiative to learn scientific innovation using multiple resources as to expand own skills and apply them in the regulatory sponsorship and day-to-day context
· Communicating the regulatory position to internal stakeholders in a firm and unambiguous way.
New Product Registrations
· Serves as primary Regulatory Affairs contact for assigned projects
· Guaranteeing the compliance of the analytical and clinical development plans with regulatory requirements of the target countries and their alignment with the specifications of each project
· Participate in project team meetings by assessing the regulatory requirements to achieve product approvals for new vaccines. Staying current with all regulatory related tasks and providing progress updates as needed
· Sponsoring and validating analytical and clinical study plans needed to obtain the marketing authorization dossier
· Reviewing and reporting issues that should be addressed before the application is submitted. Proposing corrective actions as to minimize risk at submission
· Aid in preparing detailed registration project task lists and experiments according to the set time plan
· Collecting the required data packages from project teams such as R&D, GIPI, Industrial & Quality and others
· Preparing all necessary marketing authorization dossiers for submission to regulatory authorities within set timing and ensure the overall consistency of the International dossier
· Performing technical validation of the regulatory documentation before submission; carries the responsibility that data is in full compliance before submission
· Coordinating with the different RA colleagues in the International Zone to ensure submissions are done according to projected timelines
· Responds to questions from authorities within the shortest period of time possible
· Providing cross-departmental support on technical matters throughout the entire registration process until approval
Life cycle management
· Keep the integrity of the marketing authorizations by ensuring that complete up-to-date records are maintained for compliance and guarantee of product integrity (preparation and maintenance of master files)
· Leading participation in pro-active or reactive variation procedures and assuring that specifications described in the application packages are matching with standard operating procedures while still in line with current and valid international regulations
· Supporting the respective teams on regulatory matters in the variation processes by formulating and presenting regulatory strategies; preparing the documents needed for renewal applications
· Ensuring the consistency and completeness of the technical regulatory documents for all submissions (variations, renewals, commitments, etc.)
· Responds to questions from authorities during renewal processes within the shortest period of time possible
· Additional projects or activities as assigned
|Core Competencies and Attitudinal Characteristics:|
· Shape solutions out of complexity – Work to evolve immediate environment
· Client focus – Make sure needs and requests are treated equally and in a positive way
· Collaborate with empathy – Fully takes part in the working group to share information, listens to others and have a clear idea of the decisions taken
· Engage and develop – Open to share knowledge and to receive feedback from others
· Drive ambition and accountability – Ensure accuracy of work the use of KPI’s and a responsible commitment
· Influence others -Show structure and confidence while speaking
|Technical / Functional Competencies:|
· Ability to work in a fast paced environment and possess strong organizational skills to multi-task and prioritize multiple and diverse projects
· Ability to work independently, take initiative and complete tasks based on deadline
· Demonstrates problem-solving attitude and ability to anticipate future problems or issues and be pro-active in their resolution
· Ability to network, influence and negotiate with internal and external stakeholders regarding Regulatory Affairs for Ceva’s best interest
· High level of attention to detail
· Demonstrates strong communication skills, both verbal and written
· Awareness of cultural aspects in communication and interpersonal relationships
Education – Bachelor’s degree in Veterinary, Biology, Microbiology or other science related field plus three years of relevant work experience in the production of pharmaceutical or biologic products. Master’s degree in Veterinary, Biology, Microbiology or other science related field preferred.
Work Experience – Three or more years of experience in development, production or testing of veterinary biologics. Hands-on experience using or preparing regulatory documentation supporting of veterinary biologics marketing authorization a plus.
Other (consider certifications, specialized knowledge and/or training, etc.) – Can demonstrate solid working knowledge of Latin-American, USDA or European Union regulations for veterinary immunological products a plus. Knowledge of GMP, GLP and GCP regulations a plus. Knowledge of foreign language is a plus, specifically Spanish or Portuguese.
· Must be able to read, write legibly and communicate in English
· Visual inspection.
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
*VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.
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Job posted: 2020-05-11