
Regulatory Affairs Specialist
Há 6 dias
Deliver exceptional regulatory services that drive business excellence and patient access to life-changing medicines. You will be a key player in shaping the future of our Regulatory Affairs department, ensuring compliance with local and global regulations, and advancing our mission to bring innovative treatments to patients worldwide.
As a seasoned professional in Regulatory Affairs, you will leverage your expertise to:
- Manage efficient documentation systems, record retention, and information services, maintaining accurate and compliant records.
- Identify submission components, communicate documentation standards, and coordinate the assembly of regulatory dossiers, ensuring seamless submissions.
- Stay abreast of product information, engage in continuous contacts with local, regional, and divisional customers, and maintain strong relationships with internal stakeholders.
Your success will contribute significantly to the goals and objectives of the team, driving innovation and growth while upholding the highest standards of integrity and excellence.
Requirements:
- Bachelor's degree or equivalent experience in Regulatory Affairs or a related field.
- Minimum 3+ years of demonstrated experience in Regulatory Affairs within the pharmaceutical sector.
- Proven ability to oversee and provide quality control support for others' work, ensuring accuracy and attention to detail.
- Knowledge of national and clinical trials legislation, and guidelines.
Benefits:
- Contribute to the development of complex projects, manage your time effectively to meet agreed targets, and develop plans for work activities within a team.
- Inform relevant internal stakeholders about regulatory authority approvals, ensuring timely and accurate implementation.
Key Qualifications:
- Excellent communication and interpersonal skills, with the ability to interpret and relay technical information.
- Strong analytical and problem-solving skills, with attention to detail and a commitment to accuracy.
- Ability to work independently as well as part of a team, with a focus on collaboration and mutual respect.
Awarded companies like ours strive for diversity and inclusion, fostering an environment where everyone feels valued, respected, and empowered to succeed. We look forward to welcoming talented individuals who share our passion for making a difference in people's lives.
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