Regularoy Affairs Specialist

Overview:

About us:

Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.

Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).

COMMITMENT TO EQUAL OPPORTUNITIES

Insud Pharma is aware that business management has to be in line 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 legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on 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.

Responsibilities:

Global Responsibility

Compiles and manages the Registration dossier or the Variation packages and coordinates with the Marketing Authorization Holders (licensees) and/or Post Marketing Team the submission and follow up until product approval and launch, or change implementation. Organizes regulatory information, logs and tracking. Ensure issuing AUTOS according to approved MA.

Specific Responsibilities

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.

Registration submission and follow up with Health Authorities and Licensees, until product approval and launch. Collaborate with any submission with port marketing team to achieve the objective for launching any product

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.

Collaborate with Technical- Admin RA reviewing 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.

Serves as regulatory representative to marketing, R&D teams and regulatory agencies.

Submission of dossiers during first submission waves.

Collaborating in new opportunities: submission new dossiers (EU/out of EU): submission portfolio products.

Audits

Qualifications:

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): 1-2 years of experience in the same functions.

Specific Knowledge: Very good knowledge of general pharmaceutical legislation and regulations, including GMP, and expertise in ICH guidelines and registration dossier CTD format content. Proficiency with standard software tools (Word, Excel, PowerPoint, Project, etc.).

Travels: Occasionally

Permanent