Regulatory Compliance Supervisor at Halborn

Aprilia, Latium, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Consumer Health, PharmaceuticalsIndustries

Requirements

Biological sciences, Chemistry, Pharmacy or related scientific discipline
5-7+ years in a Pharmaceutical Quality Environment
Good experience in Regulatory Affairs/CMC
Understanding of laboratory techniques
Good understanding of GMP/HACCP
English: fluent (oral and written), good presentation skills
MS Office: good command
M-ERP, Veeva: good knowledge
Team player, ability to analyse and attentive to details, good communication and influencing skills, handling of priorities, adaptability

Responsibilities

Plan the site’s regulatory activities for products under responsibility and new development projects; collaborate with Central Regulatory on planned activities (variations, renewals) and prioritization; escalate potential issues or delays
Ensure timely availability of documentation for planned regulatory submissions and RTQ; act as facilitator between Central Regulatory and plant technical functions (production, technical, engineering, analytical/stability); collaborate with worldwide affiliates on regulatory compliance
Evaluate regulatory relevance of proposed changes; participate in change control process from creation, strategy, and implementation to closure; represent regulatory viewpoint at the site’s Change Control Committee
Prepare documentation to support layouts/process/personnel flow and equipment changes for authorization by Health Authorities (e.g., AIFA or ASL) through collaboration with plant technical functions
Prepare documentation to keep updated all plant GMP licences
Identify and evaluate gaps, propose regulatory remediation, and initiate escalation process in case of non-compliance
Serve as Regulatory Compliance SME during audits and Health Authorities Inspections
Serve as Regulatory Compliance SME for all products manufactured by site in terms of compliance to central and local regulations (QRI)
Serve as Compliance SME for dietary supplements (HACCP, allergens)
Elaborate SOP and WI for all processes related to team activities and daily tasks
Coordinate ways of working with other departments and work on process improvement

Skills

Regulatory Compliance

Product Lifecycle Management

Regulatory Submissions

Change Control

Variations Management

Renewals

RTQ

Project Coordination

Documentation Management

Risk Escalation

Halborn

Cybersecurity for blockchain and digital assets

About Halborn

Halborn specializes in cybersecurity focused on blockchain technology and digital assets. The firm provides security audits, penetration testing, and consulting services to clients in the digital finance sector, including cryptocurrency exchanges and Decentralized Finance (DeFi) companies. Their services help ensure the security of digital assets and financial infrastructure by addressing the specific security threats associated with blockchain technology. Halborn stands out from competitors due to its deep understanding of both blockchain and traditional financial security, which allows them to offer tailored solutions. The company's goal is to protect businesses from security threats, ensuring the safe operation of digital exchanges and the integrity of smart contract infrastructure.

Miami, FloridaHeadquarters

2019Year Founded

$87.5MTotal Funding

SERIES_ACompany Stage

Cybersecurity, Financial ServicesIndustries

51-200Employees

Benefits

Health Insurance

Unlimited Paid Time Off

Company Equity

Risks

Increased targeting of Bitcoin hot wallets poses risks to Halborn's clients.

AI-powered social media bot farms could introduce new cyber threats.

Ongoing vulnerabilities in smart contracts remain a challenge for Halborn's services.

Differentiation

Halborn specializes in blockchain and digital asset cybersecurity, setting it apart.

The company offers high-level security audits and penetration testing for DeFi clients.

Halborn's expertise in both blockchain and traditional finance security is unique.

Upsides

Growing demand for blockchain security boosts Halborn's market potential.

Partnerships with Tholos and Orion Protocol enhance Halborn's Web3 security reputation.

Tokenized real-world assets present new opportunities for Halborn's security solutions.

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