O pozici
Medison offers hope to patients suffering from rare and severe diseases, by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.
As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead, and work relentlessly to bring therapy to patients in need, no matter where they live.
Our values are at the core of every action we take, and we are committed to going above and beyond for the benefit of the patients we serve.
We are a dynamic, fast-paced company, operating in over 35 countries across 5 continents. We are looking for out-of-the-box thinkers, people who are passionate, caring, agile and adaptive, to join us on our mission. If you are looking to make a difference in people's lives, we invite you to join us!
Co budeš dělat
- Regulatory Affairs:
responsible for the regulatory knowledge and expertise in the territory
- supports the Company’s regulatory activities by providing expert guidance and supporting cross functional decisions on aspects of regulatory affairs within the territory and the region
- acts as the primary Regulatory Affairs point of contact between the company and national Agency for Medicines and Medical Devices of Romania, coordinating and managing all relevant local regulatory affairs activities
- acts as the key liaison with Regulatory Authorities in cluster countries, ensuring effective communication, alignment, and execution of regulatory affairs activities
- supports the RA Ass. Director in all RA activities and implements the Company’s regulatory strategy
- Pharmacovigilance:
responsible for the pharmacovigilance knowledge and expertise in the territory
- supports the local pharmacovigilance activity regarding Company’s products
- serves as a local pharmacovigilance contact to the Partners and/or local Regulatory Authorities
- ensures compliance with the applicable Pharmacovigilance regulations and Medison corporate policies in the EPM region or in cluster countries under responsibility as appropriate.
- Overall responsibility for regulatory activities in cooperation with corporate functions for products where Medison is MAH and for partners’ products according to the business agreement.
- Development and implementation of regulatory strategic plans.
- Take part in identification of new RA vendors (when applicable), qualification of new and existing RA vendors. Cooperation and oversight of RA vendors in the countries under the scope of responsibility.
- Provide regulatory information/collaborate for development of the market access to align with products value proposition.
- Preparation of submission documents for approving drug codes and blue box (where applicable).
- When necessary, assist in the training of staff in regulatory policies or procedures.
- Establish regulatory priorities and budgets.
- Maintain current knowledge of relevant regulations/policies/guidelines/initiatives.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Demonstrate effective communication, collaboration and leadership with all necessary stakeholders and partners to maximize ability to execute objectives in timely manner and with efficiency.
- Represent the organization with internal & external stakeholders.
Koho hledáme
- Required Education and Experience:
Education / Knowledge
University Degree in Pharmacy, Chemistry, Biology or other Life Sciences discipline
- Knowledge of the principles of RA and PV regulations in the relevant territories and global aspects of drug safety
- Computer literate
- Language skills: local language (fluent), English (fluent)
- A minimum of 6+ years pharmaceutical industry experience with at least 4-6+ years in Regulatory Affairs area
- A minimum of 2+ years pharmaceutical industry experience in a Pharmacovigilance role
- A minimum of 1 year experience as an auditor in Pharmacovigilance Audits
- Experience in a large innovative healthcare organization preferred
- Experience working with multinational staff organizations
- Required Qualifications:
Proven ability to organize workflow activities and manage multiple critical issues
- Excellent verbal and written communication skills with proven ability to negotiate and communicate with internal and external stakeholders
- Ability to establish and maintain open, professional, and trusting relationships within the organization and with authorities
- Works effectively in highly dynamic and changing environments, displays agility.
