Regulatory Affairs Manager

Recordati

Lyon, France

This role will be involved in managing and implementing EU/US/ROW Regulatory strategies for a recently in licenced 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.

Required Education

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject.

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 international 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 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.

Technical Competencies

Previous experience of regulatory requirements for registering a new drug product in International countries;
Previous experience and knowledge of post approval regulatory activities in Europe and International countries;
Previous experience in using the centralised procedure in the EU;
Previous experience of Managing Regulatory partners/affiliates;
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.