MISSION STATEMENT
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 Life sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry, post-graduate in business or sciences as a plus.
- Regulatory experience and knowledge of pharmaceutical and regulatory processes - advantage
- Good communication skills
- Passion for accuracy and high attention to detail
- Ability to lead and managing complex projects
- Fluency in English, Czech/ Slovak - advantage
Diversity is a fact. Inclusion is an act @Zentiva
At Zentiva, we are a team of almost 5,000 unique talents bonded together by our mission to deliver high quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva!
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What We Do
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe. We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
