The Regulatory Manager is responsible for managing products under development and/or marketed products of his/her category;
He/she ensures RA input to European regulatory projects and procedures launch projects and registered products to meet business strategy and need in Italy;
Provide an efficient and proactive Regulatory support/cooperation to meet the business objectives.
Provide to GRA input for products under development and/or marketed products, and contribute on the efficient preparation of the regulatory submission and/or any type of responses document to Health Authority questions in strict cooperation with GRA and other functions (Medical, Pharmacovigilance, etc.);
Ensure maintenance and compliance of regulatory activities for existing products, Ensure that Marketing Authorizations, product packaging and associated information are updated in accordance with the current product licenses and in line with new safety information in a timely manner and inspection readiness;
Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national and European regulations;
Highlight compliance issues with all products within the portfolio and make proposals for their resolution. Actively solve issues concerning product compliance;
Develop local strategies and preparation of OTC switches;
Performs the regulatory due diligence for local BD opportunities, collaborating with other relevant functions and providing strategic recommendations to enable appropriate portfolio decision making;
Contribute and provide insight to GRA for innovation programs leading to innovative regulatory pathways to drive competitive positioning, maximize chances of approval and identify opportunities, regulatory risks and mitigation strategies;
Provide RA input to product portfolio optimization and product pruning at affiliate level and give RA input to global product portfolio optimization strategies;
Develop and maintain a comprehensive understanding and interpretation of EU and country regulatory requirements, to enable regulatory submissions to be compiled in line with current requirements;
Follow regulatory changes, competitor’s status and assess potential impact on daily activities and project strategy and Business (champion role for competitors monitoring within the CHC RA team);
Pro-actively review critical new legislation and guidance documents, share them with GRA and disseminate to relevant parties information of importance to the business;
Develop and build upon established relationships with the local Regulatory Authorities and other relevant organizations including local Pharmaceutical and Regulatory Associations, in order to facilitate activities required to meet the needs of the business. Ensure promotional and non-promotional materials compliance with local regulations, code of conduct and internal guidelines. Co-ordinate review with the responsible functions in the country.
To excel in the role, you need experience in the following tasks:
Good knowledge in local and EU regulatory legislation, procedures and guidelines governing pharmaceutical products;
Ability to work with multi-functional and multicultural teams;
Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor;
Ability to communicate effectively and efficiently with other functional departments in the business;
Good relationship ability;
Ability to resolve issues and proactivity.
Education: Physician, Pharmacist, Veterinarian or Life Sciences Degree;
Minimum of 8 years in pharmaceutical industry;
Demonstrated experiences in international and local regulatory affairs.