Regulatory Affairs Associate / Regulatory Affairs Specialist / Regulatory Analyst
Company: Pixelonn
- Location: Lower Saxony, Germany
- Seniority: Entry level
- Employment type: Part-time
- Posted: 11 days ago
- Offer language: English
Job description
Role Description
Support regulatory activities that enable product registration, market access, and ongoing compliance. This role involves preparing submission documents, reviewing product information, tracking regulatory requirements, and coordinating with internal teams and relevant authorities. Responsibilities vary by product category, market, and level of experience.
Key Responsibilities
- Prepare, compile, and maintain regulatory submissions for product registrations, renewals, and amendments.
- Review technical documents, labeling, packaging, and product claims against applicable requirements.
- Track submission timelines, approval status, registration conditions, and renewal deadlines.
- Monitor regulatory developments and assess their potential impact on products and business activities.
- Coordinate with quality, research and development, manufacturing, and commercial teams to obtain required information.
- Support responses to authority queries and requests for additional documentation.
- Maintain accurate regulatory records, correspondence, and submission databases.
- Assess product and process changes to identify potential regulatory actions.
- Support audits, inspections, and post-market regulatory activities, where applicable.
- Prepare regulatory updates and communicate requirements to relevant stakeholders.
Qualifications
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, Biomedical Science, Regulatory Affairs, or a related discipline.
- Relevant experience in regulatory affairs, quality assurance, compliance, or a related field is preferred.
- Understanding of regulatory submission processes and requirements relevant to the product category and target markets.
- Strong analytical, technical writing, and document review skills.
- Excellent attention to detail and the ability to interpret complex requirements.
- Strong organizational skills and the ability to manage multiple submissions and deadlines.
- Clear communication skills and the ability to collaborate across departments.
- Proficiency in Microsoft Office; familiarity with regulatory databases or document management systems is an advantage.
