Regulatory Program Manager

0-2 years

Not Disclosed

Budapest Remote

10 Feb. 13, 2025

Job Description

Job Type: Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Program Manager

Location: Budapest, Pest, Hungary
Category: Regulatory Affairs
Job ID: 202411-128623

Position Overview

At Roche, we are committed to fostering an environment of diversity, equity, and inclusion, which is essential to our success as we work to improve healthcare globally. As a Regulatory Program Manager, you will play a pivotal role in managing regulatory documents, compiling regulatory dossiers, and supporting internal stakeholders in maintaining high-quality regulatory standards.

Key Responsibilities

Document Management and Data Entry:
- Maintain and update regulatory documents in Regulatory Information Management (RIM) systems, document management systems (e.g., Documentum), and document-sharing systems (e.g., SharePoint).
- Prepare, update, and ensure adherence to regulatory standards (e.g., CTD - Common Technical Document) and Roche's CMC - Chemistry, Manufacturing, and Control standards.
Regulatory Dossier Compilation:
- Compile regulatory dossiers, format them for publication, and manage the handover process to the publishing team.
- Ensure accurate data entry into global regulatory systems and perform trend analysis for regulatory metrics.
Collaboration with Teams:
- Work closely with PTR product managers and internal partners to ensure smooth coordination and information exchange throughout the regulatory process.
- Actively participate in RSS (Regulatory Strategy and Support) and PTR (Pharma Technical Regulatory) initiatives to improve internal processes and practices.
Document Formatting and Technical Support:
- Assist with the detailed formatting of documents using electronic tools such as Acrobat and Word. Ensure documents are clear, consistent, and compliant with Roche's high-quality standards.

Your Profile

Education and Experience:
- A Bachelor's degree in Biology, Chemistry, Pharmacy, or a related field.
- 2-5 years of experience in a similar role within the pharmaceutical industry.
Technical Skills:
- Proficiency in Word, Excel, and Acrobat.
- Experience with document-management systems like Documentum and document-sharing platforms like SharePoint.
- Strong attention to detail, with the ability to format and maintain technical documents using electronic tools.
Soft Skills:
- Strong organizational and time-management skills, with the ability to manage multiple priorities under pressure.
- Team-oriented with the ability to work effectively with cross-functional teams and colleagues located in different countries.
- Flexibility and adaptability to meet changing priorities and deadlines in a dynamic environment.
Language Proficiency:
- Fluent in written and spoken English.

What Roche Offers You

Development Opportunities:
- Roche offers a wide range of learning resources, internal position changes, international assignments, and training programs to help shape your career.
- Access to free language courses, mentoring, and coaching opportunities.
Work-Life Balance and Flexibility:
- Competitive salary and benefits, including private medical services, employee assistance programs, and sport pass benefits.
- Flexible working conditions with 2 office days/week and the option to work fully remotely within Hungary.
Inclusive Culture and Team:
- A global, diverse community where collaboration and innovation are key to success.
- Opportunities to share your opinions and contribute to a strong, inclusive culture.

How to Apply

If you're passionate about regulatory affairs and want to contribute to Roche’s mission of improving lives, apply today by submitting your CV and any other relevant documents.

For more information on how we handle your personal data during the recruitment process, please refer to our Data Privacy Notice.

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Regulatory Program Manager

Job Description

Job Title: Regulatory Program Manager

Position Overview

Key Responsibilities

Your Profile

What Roche Offers You

How to Apply

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