Regulatory Affairs Manager
Il y a 6 mois
**Description générale**:
**_
HRA Pharma Rare Diseases_** is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world.
We have over 15 years’ experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing’s syndrome and Adrenal Cortical Carcinoma.
We are passionate about improving the lives of people affected by these conditions. We recognize that people living with rare diseases often have severe and potentially life-threatening disabilities that impact not only their quality of life, but also the lives of those who care for them. Delays in diagnosis, together with the lack of effective treatments are just some of the challenges faced by people living with a rare disease.
We’re looking for a new team member in our Global Scientific Affairs Team as **Regulatory Affairs Manager**. In this role you will be responsible for the strategy and implementation of the regulatory expertise for our 3 high-profile products, innovation projects and assigned regions.
You will ensure the maintenance of the registered products in the assigned worldwide region (European region with Mutual recognition and Centralized procedures) and proactively work towards obtaining regulatory registrations in targeted countries according to the company business growth plan. You will also actively participate in drug development projects (new indication, new formulation, new assets).
**Périmètre du poste**:
Reporting to the Senior Regulatory Affairs Manager, your main responsibilities will be:
**1. Registration activities**
- Lifecycle Management:
- Ensure the maintenance of Market Authorization files according to the post-authorization activities (variations, PSURs, renewals, annual reports, commitments follow-up, packaging change )
- Participate & coordinate responses to the questions from competent authorities
- Support the preparation, submission and/or maintenance of clinical trial dossiers (CTA, PASS, IB, IMPD, IND )
- New territories:
- Act as the interface between alliance and regulatory teams in all relevant aspects of the product registrations and development
- Explore registration opportunities and define regulatory strategy for new markets
- Manage new registrations: assess local regulations, prepare the dossiers for submission, meet authorities when needed and obtain new Marketing Authorization
**2. Drug development**
- Provide operational and strategic regulatory input to cross-functional teams for global projects
- Collaborate with external CROs when applicable
- Execute the regulatory strategies for the assigned projects
- Continuously evaluate the timelines and regulatory impacts in the overall projects
**3. Other regulatory activities**
- Ensure a regular and accurate update of our regulatory tools
- Manage third parties (contractors & service providers)
- Contribute to inspection readiness and provide support to audits and inspections activities
- Manage the Regulatory Intelligence survey of the assigned therapeutic area and region (evaluate impacts, promptly inform stakeholders, initiate actions when applicable)
**Expérience requise**:
Pharmacist/PharmD ideally completed with master’s degree in regulatory affairs you have a minimum of 10 years’ experience with regulatory affairs activity in Lifecycle management and new registrations (global) and a proven experience with European Authorities within CP and MRP. You also have a good scientific knowledge of the drug environment and international pharmaceutical regulations, experience in orphan drugs is a plus.
**Essential skills**:
- Effective and solid skills to manage complex worldwide projects and ability to summarize extensive sources of information
- Comfortable to manage multiple tasks with competing demands, conflicting priorities and tight deadlines
- Organized, rigorous and autonomous
- Ability to build and maintain excellent working relations with clients and colleagues at all levels
- Fluent in English is mandatory
We are a highly focused and agile company, committed to rare and ultra-rare diseases. By leveraging our strengths, we aim to become a company with truly sustainable growth and, ultimately, one of the most valued companies in rare disease field worldwide, come and join us
Permanent position with a hybrid work model based in Chatillon, next to metro line 13 & T6 tramway.
**_
HRA Pharma Rare Diseases is part of Perrigo. As a major player in consumer health and cosmetics, Perrigo is an American pharmaceutical company committed to supporting the health and well-being of consumers through a unique portfolio of market-leading brands._**
- At Perrigo we are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all e
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