We are currently looking for a REGULATORY AFFAIRS MANAGER that will be responsible for leading and undertaking all regulatory work necessary to meet the Healthcare needs of the RB business in Italy.
The main objective of the role is delivering the regulatory strategy for all Healthcare products across the country and ensure on-going regulatory compliance.
He/She will focus on the following activities:
· work collaboratively with the relevant Global and country teams to establish and implement the regulatory strategies for healthcare products (medicines, medical device, cosmetics and food supplements) within agreed timescales, to bring competitive advantage to RB brands;
· oversee and ensure the preparation of all regulatory documents targeted at the Italian Market;
· lifecycle management of medicinal products, cosmetics, medical devices and food supplements to ensure regulatory compliance.
· monitor, collect, interpret and apply all relevant legislation, regulatory trends and regulatory guidelines in Italy and keep the Italian business up to date on national regulatory trends, risks and opportunities; provide advice to the business as necessary and assist in developing of strategies and plans of action;
· interface with local government agencies and industry
· manage resources of HC Regulatory Team.
Reporting to the Regulatory and Medical Affairs Director, you’ll be part of a multicultural team where diversity is very high both in terms of gender and in terms of nationality, where performance and achievement are the common ground to build growth.
Requirements:
· University degree in pharmacy- life science
· At least 5 years experiences in Healthcare regulatory within a OTC – pharma company
· Valued expertise on Food supplements, Medical Devices and Cosmetics
· Fluent in English
· Thorough understanding of the current regulations, laws and industry requirements within Healthcare area
· Ability to manage workload and identify priority tasks to meet tight deadlines
· Strong influencing/communication expertise
· Ability to build good relationships and challenge constructively and confidently
· Ability to consolidate large volumes of complex information, interpret & construct straightforward plans.
Personal Attributes:
· Confident and capable of operating at all levels and able to resolve conflict situations
· Ability to challenge the status quo and propose improvement
· Able to apply appropriate problem solving techniques to evaluate and resolve operational issues