Regulatory Affairs - Human Health - Vaccines
Optional (Spain)
Ref: IF6762
November 9, 2023
OTHER
FUNCTIONS
Our client is a multinational pharmaceutical company focused on prevention and diagnosis for animal and human health, with a wide range of highly innovative vaccines and an advanced diagnostic service.
They have a solid international presence in more than 40 countries with its own subsidiaries, diagnostic centers and production plants strategically located in Europe and America.
Research and development constitute the core of its knowledge.
Currently, due to the growth of the company, they have new vacancies for Human Health Regulatory Affairs and they are looking for their Regulatory Affairs Specialist (Human Health).
Position based in the original country of the candidate with travel to Spain, Catalonia Area or locally if wanted.
Functions:
• Preparation and submission of regulatory agency applications, S.Advices, reports, or correspondance.
• Participate in meetings with Regulatory Authorities to secure product approval.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Prepare, or review regulatory submissions for domestic or international projects.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Provide support and train other RA staff proceeding from the Veterinary division, in regulatory policies, procedures, guidelines specific for human medicinal products.
• Take part in the study design protocols for safety and efficacy assessment to assure that they are in compliance with the current requirements in legislation.
• Remain always updated about laws, regulations, guidelines and policies to anticipate changes, which can affect company projects.
• Support other areas (Manufacturing, Technical Department, Quality Control, Quality Assurance, Logistics, Commercial, etc.) in the regulatory aspects of products.
Requirements:
We are looking for people who:
• Have studied a bachelor's degree in biology, biochemistry or pharmacy.
• Provide a minimum of 6-10 years of experience in a similar position in the human health vaccines (all registration process)
• High English level, Spanish will be appreciated
• Analytical, meticulous and organized
• Communication skills
• Collaborative, humble and optimistic
• A real team player, who likes teamwork
• Proactive
• Motivated and eager to learn
In our client company you can find
•Continuous learning.
• A company in full expansion, multinational.
• Multicultural environment, open to new ideas.
• Stable work positions.
