Regulatory Manager (m/w/d) Pharma

GoHiring GmbH; Titisee-Neustadt; Hybrid; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

A leading global company is seeking a Regulatory Manager to oversee strategic regulatory matters for their Pharmaceutical Business Unit. The ideal candidate will drive global regulatory strategies, ensure comprehensive compliance, and develop strong partnerships with regulatory bodies and customers. Key qualifications include significant experience in regulatory affairs, a technical degree, and fluency in English and German. This role offers a dynamic environment with flexible working options and performance-based salary.

Leistungen

Flexible working hours

Mobile working options

Extensive benefits like Hansefit and JobRad

Targeted training opportunities

Qualifikationen

• Several years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated successful engagement with regulatory authorities.
• Fluent written and spoken English and German.

Aufgaben

• Define and drive the global regulatory strategy for the Pharmaceutical Business Unit.
• Ensure compliance across all solutions while enabling market access.
• Lead engagement with key customers’ Quality Assurance and Regulatory teams.

Kenntnisse

Regulatory strategies

Compliance management

Strategic communication

GxP principles

Ausbildung

University degree in a technical or scientific field

Jobbeschreibung

The Regulatory Manager serves as the chief strategic authority for all regulatory matters within Testo's Pharmaceutical Business Unit. This pivotal role moves beyond compliance management to actively shape the regulatory landscape and convert foresight into a competitive business advantage.

You will ensure flawless global compliance across our innovative hardware, software, and service solutions while enabling strategic market access, accelerating product time-to-market, and reinforcing Testo's reputation as a trusted, pioneering partner in the digital GxP space. Regulatory excellence is a core enabler of our 2030 vision.

Key Responsibilities:

1. Global Regulatory Strategy & Foresight

• Define and Execute Strategy: Establish and drive the global regulatory strategy for the Pharmaceutical Business Unit, ensuring direct alignment with our commercial objectives and Testo’s 2030 vision.
• Anticipate Change: Proactively monitor, anticipate, and interpret evolving global regulatory requirements (e.g., GxP, data integrity, AI/digital compliance) and translate these into actionable strategic business implications for the leadership team.
• Advisory Leadership: Act as the primary strategic regulatory advisor to the Business Unit leadership, ensuring regulatory perspectives are fully integrated into product roadmaps and market access strategies.

2. Compliance Integration & Governance

• Assurance & Integrity: Own the responsibility for ensuring Testo’s entire solution portfolio consistently meets and exceeds global regulatory requirements (including FDA, EMA, MHRA, and WHO guidelines).
• Compliance by Design: Collaborate intensively with Product Management, Service, and Subject Matter Expert teams to embed compliance and data integrity requirements from the earliest stages of the product lifecycle ("Regulatory-by-Design").
• Culture and Process: Establish, standardize, and maintain robust global internal regulatory processes and mandatory training to foster a strong, proactive culture of compliance.

3. External Influence and Thought Leadership

• Shape the Environment: Proactively build and nurture high-level relationships with global regulatory authorities and industry associations to strategically influence the direction of future GxP and digital compliance standards relevant to Testo's solutions.
• Thought Leadership & Advocacy: Represent Testo in high-value regulatory working groups, consultation processes, and expert panels. You will champion Testo's vision in digital compliance monitoring, consistently positioning the company as the leading expert voice and trusted partner.
• Knowledge Transfer: Actively participate in key industry conferences and publish articles or white papers that translate complex regulatory requirements into clear, actionable thought leadership content.

4. Customer Regulatory Partnership

• Lead Direct Engagement: Lead direct engagement with key customers’ Quality Assurance and Regulatory teams.
• Trusted Partner: Use these partnerships to understand complex, real-world compliance challenges, validate Testo’s solutions, and ensure Testo is recognized as a trusted and proactive strategic regulatory partner.
• Strategic Support: Provide direct regulatory support and insight to the Strategic Account Management team to help close high-value, complex deals requiring deep regulatory validation.
• Challenging and dynamic: An exciting and dynamic environment awaits you in our global company.
• Flexibility is key: Flexible working hours and mobile working (hybrid work) are possible.
• Salary and benefits: We offer a fair and performance-related salary. You can also expect extensive benefits such as Hansefit and JobRad.
• Team: Friendly, always helpful people you look forward to seeing every morning – more than just colleagues.
• Career development: We offer targeted training opportunities and a wide range of career opportunities, including international ones. Your professional development is important to us.
• Deep Regulatory Expertise: Several years of progressive experience in pharmaceutical regulatory affairs or a quality function, with specific experience in international markets (including EMEA and US) and a proven ability to interpret and apply complex regulatory frameworks (FDA, EMA, IATA, WHO).
• Technical Background: University degree in a technical or scientific field.
• Authority Engagement: Demonstrated experience in direct, successful engagement with regulatory authorities and active participation in consultation/working groups.
• GxP Mastery: Expert-level understanding of GxP principles across the entire pharmaceutical supply chain, with specific emphasis on data integrity and the qualification/validation of hardware/software systems.
• Strategic Communication: Excellent strategic thinking and strong communication skills with the proven ability to translate complex regulatory challenges into clear, actionable business insights for executive leadership.
• Innovation Mindset: Openness to new technologies and advanced AI-based compliance solutions.
• Language: Fluent written and spoken English and German.