Regulatory Affairs Manager/Senior Manager And Compliance Support Lazio

Regulatory Affairs Manager/Senior Manager And Compliance Support
Roma
Lazio, Lazio

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals.

When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description Under the guidance of the local Director Regulatory Affairs, Quality Assurance and Compliance for Italy, this position will provide local support on these matters:

Collaboration in the technical activities of these areas in Italy across BeiGene's portfolio and throughout the clinical development and post-marketing phases of the life cycle.

Essential Functions of the Job Participation and contribution in local Regulatory Affairs activities for Italy.

Manage regulatory activities for BeiGene's portfolio through the entire product life cycle.

Manage operations related to new product launches and extension of indications.

Review and approval of local version of product information and artworks.

Manage Italian Regulatory Authority Database and update of external databases.

Manage regulatory communications to authorities.

Work with EU Functions and external partners on Bollini / serialization.

Provide regulatory guidance and procedures for ensuring regulatory compliance to departments or development project teams regarding design, development, evaluation, or marketing of products.

Communicate regulatory information to multiple departments (Medical, Market Access, Customer Engagement, etc. )

and ensure that information is interpreted correctly within the affiliate.

Provide regulatory review and approval of local promotional and non-promotional materials used in Italy.

Review all national regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

Monitor national and international legislation and perform an impact assessment where needed.

Monitor local regulatory affairs trends that are related to environmental issues.

Support the implementation of additional risk minimization measures and of safety label updates in Italy.

Formulate or implement local regulatory affairs / scientific service policies and procedures to ensure that regulatory compliance is maintained or enhanced.

Train new starters and provide refresher training to relevant staff, particularly field force about regulatory matters, scientific service matters, and internal processes.

Participation and contribution in local Compliance activities for Italy.

Support direct manager in adapting, customizing, maintaining, and validating local standard operating procedures or local working practices based on Global HCC Manual and local laws and Codes requirements.

Support Sunshine Act Transparency reporting process implementation and monitoring.

Support direct manager in managing internal monitoring and tracking deviations.

Qualifications University degree in life science / pharmacy.

5+ years of experience in the pharmaceutical industry.

Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

Ability to work effectively in a fast-paced environment.

Good interpersonal and collaborative skills, strong organizational skills, and effective written and verbal communication skills.

Fluent in English - Oral and written.

Travel Up to 10%

BeiGene Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world:

Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking / Data Analysis Financial Excellence Communicates with Clarity We are proud to be an equal opportunity employer and we value diversity.

BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law.

All employment is decided on the basis of qualifications, merit, and business need.

Summary Location: Italy Remote

Type: Full time

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