Regulatory Affairs Expert
- Adresa district Praha-východ
- Pracovní úvazek Full-time work
Leads, oversees and execute defined RA activities for new projects and all new submissions from project allocation till launch. Assures quality dossiers and defines regulatory strategies for preparation of new regulatory applications & approvals for medicinal products and medical devices in collaboration with central and local RA units.
MAIN ACCOUNTABILITIES AND DUTIES
- Preparation, monitoring and update of long term and short- term activities plan to ensure effective capacities utilization and submission on time
- Ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment
- Track and monitor queries/deficiency letters/commitments from/to Regulatory Competent Authorities to ensure these are implemented and conformed to in a timely manner
- Review and approve inspection and audit communications
- Participation on development and in-licencing new project´s teams on behalf RA, recommendation and proposal of solution for regulatory activities, effective implementation of agreed plans and strategies
- Support of Development, Business development, Portfolio and Launch teams, other Corporate functions and Affiliates on all types of new projects regulatory activities
- Definition and update or contribution to regulatory strategy for all new projects
- Definition or support of dossier content; preparation, dispatch and submission of dossiers for new submissions based on defined regulatory strategy, procedures tracking and HA questions solving
- Management of Due diligence & dossier audits for all new projects
- Assuring data administration in regulatory databases within defined New submission team responsibilities
- Identification of gaps in the RA processes and work with line manager to implement the necessary new processes (SOPs, WIs) or process revisions.
- Develop and maintain a thorough and up-to-date understanding of the regulatory environment and supporting data requirements.
REQUIRED QUALIFICATIONS & EXPERIENCE
- Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry, post-graduate in business or sciences as a plus
- Significant regulatory experience with regulatory strategic planning and development across the product lifecycle
- Ten or more years of regulatory experience in relevant discipline
- In depth knowledge of pharmaceutical and regulatory processes
- Operates from a deep understanding of business and strategies, thinks globally, looking forward the broadest possible view and able to directing and motivating others.
- Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.
REQUIRED COMPETENCIES & SKILLS
- Excellent communication skills, both verbal and written, with a passion for accuracy and attention to detail.
- Excellent interpersonal skills - ability to effectively interact with a diverse group of people from different functions, of different nationalities and at different levels within the company.
- Skilled at leading and managing complex projects.
- Leads integrated regulatory process and system improvement initiatives that will influence and build new capabilities for greater effectiveness and efficiencies.
- Leads regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
- Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures (SOPs).
- Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.
- Fluent in both written and spoken English
Zentiva je moderní zaměstnavatel, proto nabízíme široký výběr benefitů, který osloví opravdu každého.
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