Regulator Affairs Project Manager en PHARMAMAR

Regulator Affairs Project Manager
PHARMAMAR | (2) ofertas activas
Madrid, 26 Jun.
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Descripción
Pharma Mar, Pharmaceutical Laboratory based in Madrid (Spain), leader in research and Development of Oncology Products from marine samples, is selecting for its Regulatory Affairs Department a:

Regulatory Affairs Project Manager

Reporting directly to the Regulatory Affairs Associate Director, you will be responsible:

• Managing the Regulatory aspects related to the development, registration and licence maintenance of one or more R+D projects.
• To prepare, review and compile regulatory applications including investigational applications (IND. CTA, etc.) amendments, notifications, annual reports, etc, and collaborate in preparation, review and compilation of Orphan Drug Applications, Paediatric Investigational Plans, Scientific Advice Request and Marketing Authorization Applications (MAA).
• Contribute to the preparation and maintenance of labeling (i.e: labels, leaflets, SmPCs, USPI, etc).
• Collaborate in the preparation of responses to regulatory queries (CTAs, labeling, IND´s, MAAs).
• Manage and maintain regulatory databases (e.g. applications, licences, data).
• Participate in international project development teams.
• Prepare and review SOP´s.
• Assist in the design of international regulatory strategies for allocated products.
• Work closely and supervises CRO.
• Work and collaborate effectively with business partners

Numero de vacantes: 1
Tipo de contrato: Indefinido
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Requisitos
We are looking for a professional with:
- A high University Degree in Health Sciences preferably with a PhD, MSc or MBA
- A proficient level of English language and thus fluent in spoken and written English
- Excellent interpersonal , team work and project management skills
´Demonstrated good communication and negotiation skills
- Good attention to details
- Ability to work in multi-cultural and cross-functional teams
- Strong goal- and solution-orientation combined with responsibility, initiative and perseverance
- Several years of industry experience with at least 3 years’ regulatory experience
- Hands-on experience in the preparation and submission of dossiers in at least one ICH region, the preparation of documents for regulatory agency interactions, regulatory maintenance activities for authorizations in a local affiliate or head office and as a member in project teams.
- Similar project management experience
- Working knowledge of the global regulatory environment includingUS and China will be an advantage).
- Knowledge of clinical development, ideally oncology.
- Experience with electronic submission techniques-working on e-CTD would be an advantage.

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Perfecto.
Experiencia mínima
3 años
Disponibilidad para viajar
Ninguna



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