Regulatory Sciences Associate


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acum 12 luni si 3 saptamani
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AdeccoPermanent Placementis looking for its client, a global BioPharma company, aRegulatory Sciences Associate.

Duties and Responsibilities

· Works in accordance with business objectives, regulatory requirements and timeframes to ensure the timely filing and approval of products, line extensions and renewals of the company’s products.

· Execute regulatory strategic plan to ensure registration of products in accordance with business objectives.

· Prepares/support the filings for applications, variations and renewals for the products.

· Assures completion of dossiers and label reviews so products can be launched in a timely fashion.

· Interprets current national legislative/directives as relates to product licensing and registration and is able to apply changes as necessary

· Quickly recognizes potential problems in registration and takes effective steps to deal with them

· Demonstrates ability to be a strong team player by interacting with various team members to support regulatory process (medical, marketing), develops strong co-operative working relationships. Shares resources and information and is well respected by all who work with him/her

· Responsible for maintenance of regulatory databases including summary reports when necessary or on regular basis and local electronic database

· Responsible for packaging development process requests, reviews and approves artworks for packaging.

· Assists in the process of clinical trial applications, checks and archives documentation related to CTAs.

· Executes other tasks and responsibilities delegated by the Manager

· Promptly report knowledge (initial or follow-up) of any adverse event associated with a product within 24 hours or one business day of becoming aware of the event, in accordance with Company procedures.

Candidate Profile

· Pharmacy, Biochemistry, Chemistry Graduate, with 1 up to 3 years of professional experience.

· Dedicated, detailed oriented, highly organized

· Quick learner, self-motivated and team player, able to complete multi-task job effectively

· Excellent communication and writing skills

· Most important: passion for working in a fast-paced Pharmaceutical company and continuous learning within the Research & Development field.

· English – advanced (written & spoken)

· Computer skills – independent user

Core Behaviors

· Decide and Act With Speed and Rigor

· Connect and Collaborate

· Innovate and Improve

· Grow and Engage

All the candidates that fit the above requirements are kindly invited to apply online. We will contact only the suitable candidates for this position in maximum 4 weeks. For more job openings please visit our website http://www.adecco.ro and register your CV in our database to be eligible for current or future job openings. All applications are considered strictly confidential.