Regulatory Affairs Officer

Job title:

Regulatory Affairs Officer

Company:

AbbVie

Job description

Company DescriptionAbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , , and .Job DescriptionWe are seeking a highly motivated and experienced Regulatory Affairs Officer to join our team. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and a passion for ensuring compliance with regulatory standards.Responsibilities

• Maintaining appropriate regulatory dossiers for new and existing products including filing of variations to the MEB and appropriate implementation of the changes as guided by the relevant local/global procedures and according to the guidance by the MEB.
• Translation and review of product information and packaging information appropriate for the Dutch market
• Obtain marketing authorizations for new pharmaceutical products
• Liaise with European Regulatory Affairs and Corporate groups on regulatory matters

• Liaise with national regulatory authorities as required
• Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products, including participation in Brand Teams and internal discussions regarding regulatory strategies.

• e.g. communicate relevant (upcoming) changes in product information, estimation of timelines based on knowledge of legislation.
• Review of promotional and non-promotional materials in accordance with legislation, local procedures and codes of practice
• Ensure regulatory authority approval for named patient and compassionate use trials and amendments to such trials undertaken by AbbVie in the Netherlands, as required.
• When needed, obtain permission for temporary deliveries of non-registered products.
• All regulatory activities are in line with the relevant local/global procedures and national/authority guidance.
• Be a business partner to other functions including providing regulatory expertise to ensure business success.
• Support pharmacovigilance department on safety relevant matters in line with national requirements
• To support the Head of RA with budget planning, developing and meeting the longer-term goals for the department.

Qualifications

• Life sciences degree (e.g. Master’s Degree in Pharmacy, Bio-pharmaceutical sciences or related science)
• A minimum 2-5 years of relevant RA experience
• Some experience with medical devices is preferred
• Team player with leadership qualities
• Strong attention to detail, excellent organizational skills, effective communication and negotiation skills, and the ability to analyze and interpret complex regulatory documents.
• Excellent Dutch and English language skills (speaking and writing)

Additional InformationAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.US & Puerto Rico only – to learn more, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Expected salary

Location

Hoofddorp, Noord-Holland

Job date

Sun, 19 Jan 2025 05:15:10 GMT

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