Regulatory Affairs Specialist

vor 1 Monat

Berlin, Berlin, Deutschland STRAGO Vollzeit
Job Overview:

We are seeking a detail-oriented and proactive Regulatory Affairs Associate to support the preparation and submission of regulatory documents required for the approval and maintenance of products in various markets. In this role, you will work closely with cross-functional teams, ensuring that regulatory submissions comply with local and international guidelines, and contribute to the successful advancement of clinical and commercial products.

Key Responsibilities:
  • Regulatory Document Preparation:

    Assist in the preparation, compilation, and submission of regulatory documents for new product approvals, amendments, and renewals, including INDs, NDAs, MAAs, and CTAs.

  • Compliance and Monitoring:

    Ensure compliance with relevant regulations and guidelines (FDA, EMA, ICH, etc.) by monitoring changes in regulatory requirements and implementing them into submission strategies.

  • Maintain Regulatory Databases:

    Keep internal regulatory databases and document management systems updated with submission statuses, approvals, and regulatory changes.

  • Regulatory Submissions:

    Coordinate with regulatory agencies to ensure timely submission of applications and responses to questions or requests for additional information.

  • Cross-functional Collaboration:

    Collaborate with clinical, medical, quality assurance, and research teams to ensure that regulatory requirements are met across various departments.

  • Labeling and Documentation Review:

    Review product labeling and marketing materials for regulatory compliance, ensuring accuracy and adherence to regulatory standards.

  • Regulatory Strategy Support:

    Assist senior regulatory staff in developing and executing regulatory strategies for new products and changes to existing products.

  • Agency Interaction:

    Support the preparation for regulatory meetings, including drafting meeting materials, coordinating communications, and tracking follow-up actions.

Qualifications:
  • Bachelor's degree in Life Sciences, Regulatory Affairs, Pharmacy, or a related field.
  • Minimum of 1-3 years of experience in regulatory affairs, ideally within the pharmaceutical, biotechnology, or medical device industries.
  • Knowledge of FDA, EMA, and global regulatory guidelines and requirements.
  • Familiarity with submission types, including INDs, NDAs, MAAs, and other relevant regulatory filings.
  • Strong organizational skills and the ability to manage multiple projects and deadlines.
  • Excellent written and verbal communication skills, with attention to detail.
  • Proficiency in regulatory submission tools and databases.
  • Ability to work both independently and collaboratively in a fast-paced environment.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunity for professional growth and advancement within the regulatory affairs field.
  • Exposure to innovative projects in the pharmaceutical, biotech, and medical device sectors.
  • A collaborative work environment with cross-functional interaction.
  • Flexible working options, including potential remote work.

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