- Coordinate global MAA submission in collaboration with local partners/consultants.
- Define robust regulatory strategies (EU and non-EU) for MAA submissions and maintenance variations (quality/technology transfer and labelling) to achieve required changes/modifications to the product in the most effective way in terms of time and resources to be invested.
- Participation in DD processes / dossier audits
- Submission of any RA changes necessary to realise timely product launch
- Monitoring of internally set deadlines for upcoming MAA submissions, variations, RSIs
- Close co-operation with our quality departments in DE / ES on the various tech transfer projects incl. follow-up/preparation of documents for the initial and follow-up process.
- Preparation, creation, and review of Module 1 / M 2.3 / M3 and e-CTD compilation incl. publication
- Budget responsibility
- Regular communication with regulatory authorities, including building a sustainable network.
- Regular updating of internal databases (ShareMe, Veeva, RIM, e-CTD Manager)
- Lead, motivate and develop team members in line with the company's management values
- Minimum experience of 6- 10 years in a Regulatory Affairs in the Pharmaceutical Industry
- Experience in leadership and in working with international contacts.
- Proven ability to coordinate multiple projects and priorities and meeting critical deadlines.
- Experience in reviewing scientific information / participation in due diligence processes.
- Previous experience interacting with Health Authorities and Regulatory Agencies
- Degree in Pharmacy with complementary Postgraduate or Master's in the Pharmaceutical Industry or/and Regulatory Affairs
- MS Office (Excel, Power Point, Word), Data management (RIM), e-CTD software
- Key Capabilities: result-oriented, proactive, ability to deal with multiple priorities, strong interpersonal skills, and attentive to details.
- Proficient in English
- Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
- Economic conditions will be according to the experience and skills provided.
- A motivated and committed environment based on a diverse and inclusive culture.
- A specialized team focused on our core activity: Improving our patients' lives.
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Corporate RA Team Lead Launches - Sant Joan Despí, España - Neuraxpharm
Descripción
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, partnerships 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, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.
Neuraxpharm is searching a vacancy based in Barcelona, Sant Joan Despí:
Corporate RA Team Lead - Launches
You will lead the Corporate Regulatory Affairs team and will be responsible for MAA submission in ROW for our biological product BRIUMVI and maintaining the life cycle of designated marketing authorizations (EU and ROW) in compliance with global regulations and guidelines.
BEING YOUR MAJOR ACCOUNTABILITIES:
WE REQUIRE:
WE OFFER:
