Senior Regulatory Affairs Officer en ASPHALION

Senior Regulatory Affairs Officer
ASPHALION
ASPHALION (formerly Regulatory Pharma Net, S.L.) is an International Scientific and Regulatory Affairs consultancy firm based in Barcelona and Munich.

Founded in 2000, ASPHALION has consistently grown and now consists of over 60 team members with backgrounds in Pharmacy, Chemistry, Biology, Biochemistry, Biotechnology, Medicine and Veterinary Medicine.

ASPHALION operates in a global environment offering comprehensive services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies from around the world.
ASPHALION’s expertise is based on a large annual number of submissions in Europe (CP, DCP, maintenance), USA (IND, NDA, ANDA, DMF, BLA) and RoW co
Barcelona, Madrid, 23 Jul.
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Descripción
I. MAIN RESPONSIBILITIES:
Timely and correct execution of projects according to defined timelines:
•Submissions of NA, variations, renewals and procedures worldwide, including (but not restricted):
o EU
o US
o CH
o Rest of the World (RoW)
•CMC preparation and revision of documentation
o Module 3 and Module 2.3
o CMC Variations
•Pricing and Reimbursement
•Request to Health Authorities
•Due Diligence
•Data-entry of clinical trials
•Adapt the documentation to the Transparency Policy 0070
•Strategic Regulatory Advise
•Preparation and review of draft documentation
•Training on Procedure Topics
•Sales activities

According the project all activities can be done for medicinal products, medical devices, cosmetics, food supplements, biocides, and other regulated products
II. KEY ACTIVITIES:
1.Overall management of Regulatory Activities (CP, MRP, DCP, national)
2.Preparation of NA for Marketing Authorization
3.Variation assessment, submission and tracking
4.Renewal assessment, submissions and tracking
5.Post-approval changes (CMC and non-CMC changes, labelling changes and other)
6.Response to Deficiency letters and/or requests from Health Authorities
7.Product support (marketing authorization transfer, withdrawals, etc.)
8.Preparation of electronic submissions
9.Due Diligence
10.Pricing and Reimbursement
11.Timely and correct execution of projects assigned
12.Responsible person for specific client as assigned to contact point of the group
13.Responsible person for direct contact with Health Authorities
14.Communication with clients on ongoing and possible f

Numero de vacantes: 2
Tipo de contrato: Indefinido
Remuneración anual: A negociar

Ventajas sociales o económicas
•A highly professional, dynamic, ambitious & international working environment with flat hierarchies and short deci-sion paths.
•More than 12 nationalities!
•A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
•Training and personal development program.
•An organization with highly professional people to develop with.
•Flexible working schedule and Social Benefits.
•Home office implemented.

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Requisitos
Academic degree in sciences
English medium (B2 or equivalence)
Affinity of working with computers: Office, Acrobat
2 years’ experience in Regulatory and/or Scientific Affairs
2 years’ experience in project management

Estudios mínimos
Licenciado
Idiomas
Inglés nivel Alto.
Experiencia mínima
3 años
Disponibilidad para viajar
El 20% del tiempo laboral



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