Roche

Regulatory Affairs Specialist

Roche

68 Mannheim, Germany
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

We’re looking for an experienced and ambitious Regulatory Affairs Specialist to join Roche’s Regulatory Affairs team. If you have a strong regulatory background in the pharmaceutical industry, and a commitment to delivering outstanding results, we’d like to hear from you.To be successful in this role, you will need a minimum of 5 years’ experience in regulatory affairs, ideally in the pharmaceutical industry. You should have a solid understanding of regulatory requirements and a proven ability to develop and implement regulatory strategies. You should also have excellent communication and organizational skills, and be able to work independently as well as part of a team. A degree in a related field, such as life sciences, would be advantageous. If you’re looking for an exciting opportunity to take your career to the next level and make a real difference in the world of pharmaceuticals, then this could be the role for you.

Responsibilities:

  1. Develop and implement regulatory strategies and plans for products in different markets.
  2. Monitor changes in regulatory requirements and ensure compliance.
  3. Liaise with regulatory authorities and other external stakeholders to obtain necessary approvals.
  4. Prepare and submit regulatory documents and applications.
  5. Monitor and update product registrations and renewals.
  6. Develop and maintain contacts with relevant stakeholders.
  7. Provide guidance to internal stakeholders on regulatory requirements.
  8. Conduct research and analysis in order to stay up to date with current trends and developments in the regulatory environment.
  9. Prepare reports and presentations on regulatory matters.
  10. Ensure that all regulatory activities are carried out in compliance with relevant laws and regulations.
Where is this job?
This job is located at 68 Mannheim, Germany
Job Qualifications
  • Excellent Communication Skills

  • Strong Attention To Detail

  • Highly Organized

  • Proven Ability To Multi-Task

  • Experience With Regulatory Compliance And Documentation

  • Experience In Pharmaceuticals Or Medical Device Industry

  • Knowledge Of Fda And International Regulations

  • Familiarity With Industry Standard Software Programs

Required Skills
  • Quality Assurance

  • Data Analysis

  • Communication

  • Database Management

  • Auditing

  • Compliance

  • DOCUMENT CONTROL

  • Project coordination

  • FDA regulations

  • Policy Development

  • Clinical Trials

  • Product Registration

  • Regulatory Strategy

  • Submission Management

  • Regulatory Processes

Soft Skills
  • Communication

  • Leadership

  • Problem Solving

  • Time management

  • Interpersonal Skills

  • Organization

  • self-motivation

  • Critical thinking

  • Teamwork

  • Adaptability

Compensation

According to JobzMall, the average salary range for a Regulatory Affairs Specialist in Mannheim, Germany is €48,000-€60,000 per year. This range can vary depending on a number of factors, such as experience, qualifications, and the specific organization or industry.

Additional Information
Roche is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesGerman
Job PostedOctober 6th, 2023
Apply BeforeMay 22nd, 2025
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About Roche

Roche Holding AG operates as a research healthcare company. It operates through the diagnostics and pharmaceuticals segments. The pharmaceutical segment refers to development of medicines in the field of oncology, immunology, ophthalmology, infectious diseases and neuroscience. The diagnostic segment refers to diagnosis of diseases through an in vitro diagnostics process.

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