Recordati Hemel Hempstead, England, United Kingdom
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Recordati Hemel Hempstead, England, United Kingdom
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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 involves managing and implementing EU/US/ROW regulatory strategies for a recently licensed product. Responsibilities include developing regulatory strategies, leading submissions such as variations, renewals, and CTAs, managing submissions for new marketing authorizations globally, and coordinating with local partners to maintain licenses.
Key Responsibilities
* Manage and implement EU/US/ROW regulatory strategies for assigned products.
* Lead resolution of regulatory risks, escalate issues, and monitor progress.
* Support clinical trial applications, scientific advice procedures, orphan designations, and PIPs for new indications.
* Manage post-approval submissions in EU/US and ROW countries with CROs and partners.
* Provide regulatory support to project teams.
* Manage CROs and partners in registered territories.
* Prepare and submit post-approval variations, renewals, PSURs, and other activities to maintain licenses.
* Contribute to strategies for interactions with health authorities.
Required Education
Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field.
Required Skills and Experience
* Ability to manage multiple projects independently and within teams.
* Strong stakeholder relationship skills for prompt regulatory approvals.
Technical Competencies
* Experience with registering drugs in ROW countries.
* Knowledge of post-approval regulatory activities in EU/ROW.
* Experience with EU centralized procedures is an advantage.
* Managing regulatory CROs experience.
* Experience with CTA applications in the EU.
Required Behaviours and Competencies
Excellent communication and collaboration skills, with experience in global regulatory planning.
Languages
Fluent English, additional languages are a plus.
Travel
Limited travel required.
At Recordati, we believe in people! We are committed to diversity and inclusion, recruiting and developing without regard to gender, sexual orientation, gender identity, age, race, ethnicity, or ability. If you want to join a company that encourages innovation and openness, apply today. #J-18808-Ljbffr