Regulatory Affairs Submission Manager Job Description
We are seeking an experienced Regulatory Affairs Submission Manager to join our team. This role offers a unique opportunity for professional growth and development in a dynamic environment.
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Key Responsibilities:
* Initiate, coordinate, and supervise the registration of medicinal products through European procedures or national submissions across regions.
* Develop submission strategies for each project, aligning with applicable requirements and assigning due dates.
* Direct and coordinate document preparation for regulatory submissions, adhering to European regulations and local pharmaceutical laws.
* Ensure timely responses to authorities' requests.
* Communicate with third parties to expedite submissions and ensure regulatory compliance.
* Provide support for sample preparation and dispatch when necessary.
* Inform relevant functions on project status and progress.
* Compile, verify, and publish submissions using electronic publishing software.
* Document and track regulatory processes within the organization.
Requirements:
* 5+ years of experience in regulatory affairs with a focus on submissions.
* Strong knowledge of ANVISA regulations and health authority requirements.
* Ability to work effectively without direct supervision.
Benefits:
* Exciting Challenges: Every day brings new opportunities to learn and grow.
* Supportive Environment: We foster a culture of collaboration.
* Career Development: We help you reach your full potential through ongoing training and development opportunities.
* Recognizing Excellence: We recognize and appreciate hard work and dedication.
* Fun and Inclusive Culture: We celebrate our successes and build strong connections within our team.