IZ Regulatory Affairs Specialist
Location: Kansas City, Kansas
Description: CEVA Animal Health, LLC is currently seeking to employ IZ Regulatory Affairs Specialist right now, this occupation will be designated in Kansas. More details about this occupation opportunity kindly see the descriptions.
IZ Regulatory Affairs Specialist
Location: Lenexa, KS
Job Summary and Purpose:
The Regulatory Affairs Specialist for the AMEET Zone is responsible for the preparation of dossier (part 1, 2, 3, 4) or variation (part 1, 2, 3 and 4) for new or existing vaccines for International countries of the AMEET Zone. Takes care of the regulatory life of new and existing products (including preparation of technical documents, e.g. Responses to Questions, and administrative documents) and paying particular attention to the strategic biological products handled by the Regulatory Affairs Department.
Responsibilities and Key Duties:
- Keeping track by own initiative of the currently valid and draft international regulations and ability to transfer and apply the new knowledge to the daily work.
- Serving as primary technical regulatory affairs contact for assigned projects related to bacterial, viral and parasitic vaccine development, demonstrating ability to advice on aspects for whole cell, subunit, recombinant and GMO vaccines.
- Guaranteeing the compliance of the analytical and clinical devel opment plans with regulatory requirements of the target countries and their alignment with the specifications of each project.
- Participating in project team meetings and assisting in designing vaccine development by assessing the regulatory requirements to achieve product approvals. Following up the tasks with registration relevance and presenting the progress as required.
- Sponsoring regulatory analytical and clinical study plans needed for the marketing authorisation dossier and validating the study reports relevant for the dossier.
- Reviewing and reporting issues that should be addressed before the application is submitted and proposing corrective actions as to minimise 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 units and others.
- Preparing the necessary marketing authorisation dossiers for submission to competent authorities within set timing and ensure the overall consistency of the International dossier.
- Performing technical validation of the regulatory documentation before submission to International countries.
- Coordinating with the different RA managers in the AMEET Zone to ensure submissions are done according to projected timelines.
- Keep the integrity of the marketing authorisations by ensuring that complete up-to-date records are maintained for compliance and guarantee of product integrity (preparation and maintenance of Master files).
- Proactively working on the implementation of compliance with currently valid applicable and international regulation (VICH, OIE, etc.).
- Leading participation in pro-active or reactive variation procedures and assuring that specifications described in the application packages are matching with standard operating procedures meanwhil e conforming to valid international regulations.
- Supporting the respective teams on regulatory matters in the variation processes. Ability to formulate and present regulatory strategies.
- Reviewing and reporting issues that should be addressed before the application is submitted and proposing corrective actions as to minimise risk at submission.
- Coordinating with the Zone RA managers to ensure submissions are done according to agreed timelines.
- Performing technical validation of the regulatory documentation before submission and carries the responsibility that data are in full compliance before documentation is submitted.
- Ensuring the consistency and completeness of the technical regulatory documents for all submissions.
- Responding to questions from authorities during procedures (new dossier, variations, etc.) within the shortest period of time.
- Giving cross-departmental support on technical matters throughout the whole registration process until approval.
- Actively participating in the development of new legislation, guidelines or standards directly or indirectly
- Utilizing expert technical regulatory skills to influence regulators on complex issues.
- Interacting with regulatory authorities in a persuasive manner for their understanding and acceptance of proposed regulatory approaches.
- Taking initiative to self-learning and learning on the job and pro-actively keeping track of new legislation and 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.
- Advise internal stakeholders of the impact of current, newly finalized or proposed regulations and guidelines.
- In addition to the responsibilities listed above, he/she is responsible for projects or ac tivities as assigned by management.
Core Competencies and Attitudinal Characteristics:
- Glass Half Full - demonstrates an enthusiasm for building and growing a business. Not discouraged by momentary failure. Does not make excuses. Focuses on the upside and what is within your control.
- Solutions Partner - takes ownership for solving problems. Develops creative ways to keep or win business. Takes the initiative; does not wait to be told what to do. Seeks self improvement.
- Work Ethic - self-driven and self-motivated. Does what it takes to get the job done and then some.
- Has a Plan and Works It - manages the work assigned as though it is your own business.
- Flexibility / Embraces Change - embraces new ideas and new ways of working. Continuously seeks to improve the work environment and the job itself.
Technical / Functional Competencies:
- Ability to multitask in a fast paced environment with strong organisational skills to coordinate multiple and diverse projects simultaneously.
- Sense for pro-active behavior and taking initiative, making recommendations.
- Can determine how a system should work and implement improvements when needed. Demonstrates problem-solving attitude and ability to anticipate.
- High level of attention to detail.
- Demonstrated organization, strong communication and interpersonal skills.
- Awareness of cultural aspects in communication and interpersonal relationships
Qualifications:
Education
Veterinarian, biologist, microbiologist, chemist, pharmacist or agriculture engineer
Work Experience
At least 3 years of experience with the administrative, analytical and clinical parts of marketing authorisation dossiers, including ne w and post-approval applications, is required. Alternatively, other relevant experience in pharmaceutical product development..
Can demonstrate solid working knowledge on European Union-like regulations for veterinary immunological products.
Knowledge of GMP, GLP and GCP regulations is preferred.
Knowledge of foreign languages of the AMEET zone (French, Arabic, Russian,etc.) is an advantage.
Other (consider certifications, specialized knowledge and/or training, etc.) -
Physical Requirements:
Travel Required:
If the job requires overnight or international travel, indicate which as well as the percentage of time.
Occasional international travel (<5%).
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work perfo rmed 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.
669B
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This occupation starts available on: Thu, 17 May 2018 12:39:10 GMT