Career Opportunities: Junior Technical Coordinator RA
Junior Technical Regulatory Affairs Coordinator
Neuraxpharm is looking for people who want to make a difference and improve patients' lives within the CNS area. We want individuals who will go the extra mile and make great things happen.
Being part of this team does not mean you are just working for a company, but for a cause
Neuraxpharm is looking for a Junior Technical Regulatory Affairs Coordinator based in Barcelona (hybrid role)
Temporary Contract
Your mission:
Management and control of the exchange of documentation and information related to the regulatory procedures derived from the commercial B2B/B2C activity at international level. All according to client's satisfaction criteria and internal priorities, so that there is a single consensual response for each query received through clients, agents, regulatory agencies or internal departments of the company.
Coordinate projects since contract is signed until launch (with continuous contact with both clients and internal teams to review status. And send variation packages to clients and do continuous follow-up until approval.
Additionally, he/she will be responsible for preparing, managing and submitting the documentation required for the maintenance of our existing Marketing Authorizations (MAs) & relevant dossiers to the Health Authorities, in accordance with the quality criteria and company policy.
Your major accountabilities:
* Evaluation and filter of each technical request before processing them to the internal teams (answering directly, asking for clarifications when necessary, offering alternatives...). All with the aim to limit the charge of internal work to the necessary regulatory support.
* Process the external queries in less than 48 hours and link them to previous historic communications in order to facilitate the elaboration of the answer. Release of the internal feedback in less than 24 hours.
* Maintain traceability of the history of topics through the databases associated to the position. Organize and update databases and information.
* Follow up of the tasks opened with the responsible teams in charge of the answer from the different supportive units of the company, developing good working relationships with them.
* Maintain continuous feedback with customers about the information/documentation they are waiting for (timelines, causes for delays, reasons for not giving something…).
* Monitor the full registration process of each product in each country from the initial request of documentation when commercial agreements are signed, until the launch of the product.
* Update the documentation of authorized products, through the preparation, submission of variations to the health authorities and follow-up until the resolution is obtained.
* Prepare the documentation for national and international customers and give support until the granting of the marketing authorization.
We would like you to have:
* Minimum experience of 2 years in Regulatory Affairs.
* Minimum experience of 1 year in tasks of coordination related with the registration and commercialization of medicinal products for human use.
* Knowledge of Development of Pharmaceuticals drugs.
* Adequate knowledge of registration procedures & International Regulatory requirements.
* Experience in Project Management.
* Organized, planned, strong team spirit with negotiating skills.
ABOUT US
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.
The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.
Be part of the team where you can count on us to deliver:
* Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
* Attractive remuneration according to the experience and skills provided.
* An inspiring leadership team that drives performance.
* An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, dynamic, result-focused, and expert & excellent team
Interested in knowing more?
Have a look at what Neuraxpharm culture represents and what makes us such a great place to work:
If you want to join us, this is your opportunity
WE COUNT ON YOU
At Neuraxpharm, diversity, equity and inclusion is foundational in the way we operate. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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