Senior Associate Regulatory Affairs
Senior Associate Regulatory Affairs
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Job Description
About This Role
As a Senior Associate Regulatory Affairs you will support the Affiliate Regulatory Head in delivering operational support aligned with the strategic goals of the affiliate. Your primary focus will be on managing local operational regulatory activities to contribute to the latestage pipeline and marketed products working closely with relevant affiliate staff. Additionally you will ensure compliance with comprehensive and uptodate national regulatory guidelines and requirements facilitating the successful execution of regulatory activities in the country.
What Youll Do
- Review and update Spanish translations of Product Information (PI) including SPC PIL and labels ensuring compliance with local regulations and maintaining highquality standards.
- Create PI versions for promotional materials and disseminate updates within the affiliate to ensure adherence to local procedures while maintaining an uptodate local repository.
- Manage all aspects of artworkrelated activities including creation review approval and handling deviations ensuring alignment with regulatory requirements.
- Prepare submit and track regulatory submissions with National Competent Authorities (NCA) through the National Electronic Application System addressing local requirements such as fragmentation of texts educational materials DHPCs and national codes applications.
- Conduct operational regulatory activities to ensure compliance with local requirements while aligning with EU strategies and business priorities adhering to established timelines.
- Maintain and oversee official and local regulatory databases ensuring data accuracy and timely updates to support regulatory operations.
- Review and approve promotional and nonpromotional materials ensuring compliance with local regulations company standards and best practices while monitoring key compliance metrics.
- Support the Affiliate Regulatory Head with audits inspections and the implementation of the Quality Management System (QMS) and manage regulatory procedures and policies within the affiliate.
- Collaborate with crossfunctional teams such as QA PV Marketing and Medical Affairs to provide regulatory operational support and ensure cohesive alignment across functions.
- Provide regulatory operational support to subcluster countries as needed addressing unique regional requirements and ensuring consistent practices across borders.
Qualifications :
Who You Are
You are an adaptable and resourceful professional with a passion for delivering results in a dynamic regulatory environment. Your experience in pharmaceutical regulatory affairs equips you to manage technical and strategic tasks adapt to daytoday changes and take ownership of responsibilities. You thrive in innovative collaborative settings and demonstrate flexibility accountability and a commitment to professional growth.
Required Skills
- Degree in Health Sciences (Pharmacy Biology or related fields) with a postgraduate specialization or masters in Regulatory Affairs in the pharmaceutical industry.
- 12 years of experience in regulatory affairs within an innovative pharmaceutical company or a combination of internship experience and relevant professional exposure.
- Fluency in Spanish advanced English skills (C1 minimum) with Portuguese as a plus.
- Familiarity with tools such as RAEFAR PLM Veeva Insights and National Regulatory Databases.
- Proven ability to review translations manage regulatory submissions (e.g. dossiers) and oversee compliance with regulatory materials.
- Strong interpersonal skills to build trust and inspire confidence while working across all organizational levels.
Preferred Skills
- Ability to handle technical tasks such as auditing maintaining databases and preparing regulatory materials with accuracy.
- Understanding of decentralized licensing and the ability to navigate local regional and EU regulatory environments.
- Experience working within innovative pharmaceutical companies focusing on nongeneric products.
- Flexibility to collaborate within a regional team and manage evolving responsibilities as part of a broader organizational structure.
Additional Information :
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
