With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life. Regulatory Affairs Manager
This role will be involved in managing and implementing EU/US/ROW Regulatory strategies for a recently in-licensed product. The role will involve managing and participating in the development and implementation of regulatory strategy for specific programmes and may take the lead on the design and execution of certain sections of regulatory submissions such as variations, renewals and CTA applications. It will also involve managing the submission of ongoing and new marketing authorisation applications in rest of world countries. The role will require managing the regulatory activities with Recordati’s local partner representatives in order to register and maintain the relevant marketing authorisations/licences in certain countries. Key Responsibilities
Responsible for managing and implementing EU/US/ROW regulatory strategies in support of the assigned product. Lead issue resolution of regulatory risks by identifying, escalating and monitoring issues. For any new indications in development to be primarily involved in the preparation and submission support for clinical trial applications, scientific advice procedures, orphan designation requests and Paediatric Investigation Plans (PIPs). Manage post-approval submissions in approved territories (EU/US) as well as managing the submission process in ROW countries (in conjunction with CROs/Partners). Provide regulatory support to project teams for allocated projects. Manage CRO and partners in territories where the product is registered. To be responsible for planning, preparation and submission of post-approval variations, renewal documents, post-marketing commitment submissions, PSURs and other ad hoc activities in support of maintaining the marketing authorizations. Contribute to and implement strategy for interactions and negotiations with health authorities. Required Education
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject. Required Skills and Experience
Ability to work independently on multiple projects and within functional teams. Ability to build relationships with key stakeholders both internally and externally in order to obtain prompt regulatory authority approvals. Previous experience of regulatory requirements for registering a new drug product in ROW countries. Previous experience and knowledge of post-approval regulatory activities in EU/ROW. Previous experience in using the centralised procedure in the EU would be an advantage. Previous experience of managing Regulatory CROs. Experience with CTA applications and procedures in the EU. Required Behaviours and Competencies
Communication and collaborative skills. Experience preparing, developing and implementing successful global regulatory planning. Required Languages
Excellent written and spoken English. Any other language skills would be an advantage. Travel required in %
Limited travel required.
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We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life. Regulatory Affairs Manager
This role will be involved in managing and implementing EU/US/ROW Regulatory strategies for a recently in-licensed product. The role will involve managing and participating in the development and implementation of regulatory strategy for specific programmes and may take the lead on the design and execution of certain sections of regulatory submissions such as variations, renewals and CTA applications. It will also involve managing the submission of ongoing and new marketing authorisation applications in rest of world countries. The role will require managing the regulatory activities with Recordati’s local partner representatives in order to register and maintain the relevant marketing authorisations/licences in certain countries. Key Responsibilities
Responsible for managing and implementing EU/US/ROW regulatory strategies in support of the assigned product. Lead issue resolution of regulatory risks by identifying, escalating and monitoring issues. For any new indications in development to be primarily involved in the preparation and submission support for clinical trial applications, scientific advice procedures, orphan designation requests and Paediatric Investigation Plans (PIPs). Manage post-approval submissions in approved territories (EU/US) as well as managing the submission process in ROW countries (in conjunction with CROs/Partners). Provide regulatory support to project teams for allocated projects. Manage CRO and partners in territories where the product is registered. To be responsible for planning, preparation and submission of post-approval variations, renewal documents, post-marketing commitment submissions, PSURs and other ad hoc activities in support of maintaining the marketing authorizations. Contribute to and implement strategy for interactions and negotiations with health authorities. Required Education
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject. Required Skills and Experience
Ability to work independently on multiple projects and within functional teams. Ability to build relationships with key stakeholders both internally and externally in order to obtain prompt regulatory authority approvals. Previous experience of regulatory requirements for registering a new drug product in ROW countries. Previous experience and knowledge of post-approval regulatory activities in EU/ROW. Previous experience in using the centralised procedure in the EU would be an advantage. Previous experience of managing Regulatory CROs. Experience with CTA applications and procedures in the EU. Required Behaviours and Competencies
Communication and collaborative skills. Experience preparing, developing and implementing successful global regulatory planning. Required Languages
Excellent written and spoken English. Any other language skills would be an advantage. Travel required in %
Limited travel required.
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