Global Regulatory Affairs Specialist - Labeling and Pharmacovigilance
Today• Tres Cantos, Spain
Job Description Summary
As Global Regulatory Affairs Specialist - Labeling and Pharmacovigilance you will be responsible for the development and maintenance of Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), packaging mockups, and advertising/promotional materials for medicinal products. Additionally, this role supports the maintenance of Instructions for Use (IFU) for medical devices and contributes to pharmacovigilance activities in close collaboration with the Pharmacovigilance and Medical Affairs teams.
Job Description
Main responsibilities will include:
- Lead and coordinate the preparation and the review of SmPC, PIL, mockups, and ad prom material.
- Represent the RA team in Pharmacovigilance projects and meetings. Review, and report pharmacovigilance data. Contribute to the preparation of PV documents.
- Maintain and protect existing licenses in international, ensuring compliance with local regulations.
- Review and approve change control / design control impacting packaging and artworks to ensure regulatory compliance.
- Ensure that the pharmaceutical products sold in international meet the local regulatory requirements.
- Liaise with the Infection Prevention team (local office or local distributors, manufacturing, quality, R&D, regulatory) to ensure effective submissions in the targeted markets.
- Provide timely support when requested by these organizations in preparing necessary regulatory and labeling documents, submitting these documents in a timely manner and maintaining an adequate archiving system.
- Maintain the database in which all registrations made in these territories are documented.
- Report to his direct manager on the performance of the regulatory process system and registration timelines.
- Maintain knowledge of specific regulatory requirements for targeted markets.
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About you
- Life science degree (Pharmacist or Chemical Engineer)
- Proven experience in regulatory labeling and pharmacovigilance in the pharmaceutical industry
- Strong experience in labeling, experience in the preparation and the review of CTD is a plus
- Knowledge of drug pharmaceutical requirements (clinical studies, pharmacovigilance, variations, renewals- Medical devices and biocides knowledge is also a plus)
- Proficient English level
Salary range for this role: 35000€ - 45000€
Click on apply if this sounds like you!
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A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.
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Our vision for Regulatory Affairs at BD
The Regulatory Affairs team is helping to ensure speed to market for BD's innovative medical technologies by having an acutely patient-centric mindset.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
To learn more about BD visit:https://bd.com/careers
Required Skills
Optional Skills
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Primary Work Location
ESP San Agustin del Guadalix
Additional Locations
Work Shift
At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed.
The salary or hourly rate offered to a successful candidate is determined by their experience, education, and skills, as well as the labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location.
Salary Range Information
€31,800.00 - €57,200.00 EUR Annual
Client-provided location(s): Tres Cantos, Spain
Job ID: BD-87356570688
Employment Type: OTHER
Posted: 2025-10-18T18:46:06
Perks and Benefits
Health and Wellness
Parental Benefits
Work Flexibility
Office Life and Perks
Vacation and Time Off
Financial and Retirement
Professional Development
Diversity and Inclusion