
Regulatory Affairs Specialist
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:
- Develop and implement regulatory strategies and plans for products in different markets.
- Monitor changes in regulatory requirements and ensure compliance.
- Liaise with regulatory authorities and other external stakeholders to obtain necessary approvals.
- Prepare and submit regulatory documents and applications.
- Monitor and update product registrations and renewals.
- Develop and maintain contacts with relevant stakeholders.
- Provide guidance to internal stakeholders on regulatory requirements.
- Conduct research and analysis in order to stay up to date with current trends and developments in the regulatory environment.
- Prepare reports and presentations on regulatory matters.
- Ensure that all regulatory activities are carried out in compliance with relevant laws and regulations.
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
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
Communication
Leadership
Problem Solving
Time management
Interpersonal Skills
Organization
self-motivation
Critical thinking
Teamwork
Adaptability
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.
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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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