Regulatory Affairs Associate

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INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.

The activities of INSUD PHARMA are organized into three synergistic business areas : Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

Ready to be a #Challenger?

What are we looking for?

We are incorporating a new INSUDER as Regulatory Affairs Associate at our plant in León.

The Challenge!

Understand the needs of each customers and project and align them with the strategic guidelines of Chemo.

To stay updated on changes in legislation and regulations and advises and gives interpretation on the potential impact to the product registration, marketing, manufacturing or development.

To advice R&D team on Regulatory requirements for registration dossier.

Compilation of required information for registration dossiers and for notifications (pharmaceutical products, food supplements and cosmetics)

Registration submission and follow up with Health Authorities and Licensees, until product approval and launch.

Coordinate the submission and the approval for the Free Sales Certificates.

Coordination and preparation of Answers to deficiencies letters received from Health Authorities.

Maintains regulatory files / database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or licensees.

Reviews product labelling for compliance with regulatory requirements.

Review and advice on product changes for impact on regulatory filings worldwide.

Technical support to the sales department with the technical requirements of the customers.

Serves as regulatory liaison throughout product lifecycle.

What do you need?

Education : Degree in Pharmacy, Chemistry or Biology. Master is a plus.

Languages : Fluent Spanish and English, knowledge of other languages will be an asset.

Experience (years / area) : 1 year of experiencie

Specific Knowledge : Very good knowledge of general pharmaceutical legislation and regulations, including GMP. Experience with standard software tools (Word, Excel, PowerPoint, Project, etc.).

Our benefits!

Attractive salary package.

Permanent Contract. Full time from Monday to Friday

Training and experience in a strategic and constantly growing sector.

We are characterized by a professional, close, and teamwork-oriented environment.

What will the Selection process be like? ️

➡️ Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.

➡️ Prepare well! We will continue with an in-person / virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.

➡️ Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

Do you think this offer is not for you?

Follow us on social media like LinkedIn / Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting!

#InsudPharma #Challenger #Insuder #InsudTalent

COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3 / 2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.