Principal Business Consultant – R&D – Regulatory
Location
Germany
Posted
110 days ago
Salary
0
Seniority
Lead
Job Description
Principal Business Consultant – R&D – Regulatory
Veeva Systems Inc
• Lead business development opportunities – identify and generate new project opportunities, clarify customers challenges and needs, be able to develop a compelling, differentiated proposal to solve these issues, and win new work • Leverage your network to identify opportunities and develop our business and build new relationships • Be the R&D consulting lead on one of our top enterprise accounts • Build strong and trusted relationships with customers, serving as primary contact for strategic and tactical questions • Support in the creation of new campaigns, offerings, and thought leadership that differentiate R&D consulting in the market • Lead multiple project engagement teams – empowering the team to plan and manage all aspects of delivery, from scope to quality assurance
Job Requirements
- Significant management and R&D consulting experience (at least 10 years)
- Experience in the Life Sciences, particularly in Regulatory Affairs and Regulatory Information Management
- An extensive network of relevant stakeholders within leadership positions in Top 20 Life Sciences companies
- Credibility and experience in operating and engaging at senior levels with key Life Sciences customers
- Proven track record of developing new, high value/impact, customer engagements
- Demonstrated experience in designing and implementing digital transformation and R&D innovation/improvement programs
- Deep understanding of the entire R&D value chain
Benefits
- Highly competitive remuneration
- Opportunity for rapid progression
- Health & wellness programs
Related Guides
Related Categories
Related Job Pages
More Compliance Jobs
Supplier Compliance Engineer
OnticLeading global aerospace OEM, providing complex engineered parts & repair services in the defense and commercial market
Supplier Compliance Engineer Location: Gloucestershire or Remote (with significant travel) Ontic, a leading licensor and manufacturer of complex engineering parts for the global aerospace and defence industries, are now recruiting for a Supplier Compliance Engineer to join our Quality Compliance team where you'll support us in ensuring our global supply chain consistently meets the highest aerospace standards. This role can be based in Gloucestershire or remotely, with regular international travel required. Ontic is more than just a business, we're a community of innovators who pride ourselves on fostering a culture where talent thrives, ideas flourish, and careers are built. We're committed to excellence, driving us to continuously improve and adapt, ensuring that we remain at the forefront of our industry. The Role: As a Supplier Compliance Engineer, you’ll play a critical role in maintaining a compliant and high-performing supply chain, ensuring our suppliers meet stringent aerospace quality and regulatory standards. You’ll be responsible for conducting supplier audits, supporting onboarding and qualification activities, and driving improvements in supplier performance and compliance. Working closely with both suppliers and internal stakeholders, you’ll lead the investigation and resolution of supplier-related quality issues, ensuring effective containment and robust root cause analysis. You’ll also carry out source inspections at supplier sites, ensuring product conformity prior to shipment and alignment with engineering and customer requirements. This is a highly visible, field-based role requiring regular travel to supplier sites (up to 80%), where you’ll act as a key partner in strengthening supplier capability, improving processes, and embedding a culture of continuous improvement across the supply chain. About you: At Ontic, our culture is integral to making sure we enjoy our work and deliver for our customers. While we look for the right skillset, we're also looking for someone who will thrive within our recognition and empowerment culture. To be successful in this role, you’ll bring strong experience within supplier quality, compliance, or manufacturing in a regulated industry such as aerospace. You’ll have a deep understanding of relevant standards such as AS9100 and hands-on experience conducting supplier audits and managing quality issues through to resolution. You’ll be confident working independently in a field-based role, building strong relationships with suppliers while also influencing and collaborating with internal teams. Strong problem-solving skills, including the use of recognised root cause analysis methodologies, are essential, along with the ability to communicate clearly and produce detailed, high-quality reports. A proactive and resilient mindset is key, as is the flexibility to travel extensively, including internationally. A relevant engineering qualification and Lead Auditor certification would be highly advantageous. Benefits At Ontic we care about your financial, physical, and mental wellness so we offer a range of benefits to support this. We care about what matters to you and have a valued culture of recognition and empowerment, accompanied by benefits that support work/life balance. Our benefits package highlights include: - Up to 29 days annual leave plus Bank Holidays - 10 hours paid volunteering time - Annual goal share bonus scheme for all employees - 24/7 Employee Assistance Program (EAP) - Discounts and offers from a range of retailers Best place to work We are more than the sum of our parts. And we’ve been recognised internally and externally for being so: - We were ranked #9 in Best Companies’ Q3 leaderboard for Best Manufacturing Company based on our employee feedback - 72.5% of employees who took part in our 2023 employee satisfaction survey said they are proud to work at Ontic No day is the same at Ontic; we have doubled in size over the last couple of years and are still in rapid growth. We attribute our success to empowering colleagues to create the opportunity, fostering an environment of autonomy where we ask for forgiveness, not permission. Our values Our values are intrinsic to everything we do: - We share a common sense - we’re a global family of specialists with a shared passion for precision. - We have the freedom to choose - we’re challengers and innovators with the freedom to think differently and challenge the status quo. - We create the opportunity - we’re change-makers with a clear direction and can-do spirit. We are a fast-paced business with ambitious growth plans; so if you are dedicated, enthusiastic and always seeking ways to improve, you'll enjoy a career with us!
• Oversee and maintain all state mortgage licenses for Realfinity Mortgage • Ensure ongoing compliance with state and federal regulations (NMLS, RESPA, etc.) • Act as the designated AML/Compliance Officer in applicable states • Coordinate license renewals, updates, and reporting • Support internal audits and regulatory filings • Stay ahead of regulatory changes impacting our operation.
• Develop, implement, and maintain information security policies, standards, and procedures. • Identify, assess, and manage information security risks. • Ensure adherence to relevant laws, regulations, and standards. • Prepare and present regular reports on the status of information security to management and CISO. • Review of 3rd party vendors to ensure the security control compliance.
Inspections Compliance Analyst – GxP
ClarioTransforming Lives by Unlocking Better Evidence | Decentralized clinical trials | Broadest endpoint technology
The Inspections Compliance Analyst - GxP coordinates and manages assigned Quality Management regulatory inspection and audit activities and supports management and evaluation of identified potential regulatory concerns per the Quality Management System’s (QMS) activities to ensure corporate compliance with regulatory authorities and industry expectations.ESSENTIAL DUTIES AND RESPONSIBILITIES: Under the supervision of the Manager Inspections Compliance - GxP, support the execution of regulatory inspection and audit activities of all regions to include coordination of resources, data, or documents. Promote the Continuous Improvement program through management of issues to ensure accurate root cause analysis, corrective/preventive action implementation and confirmation of effectiveness. Assist with the hosting and management of regulatory inspections for both CLARIO and CLARIO clients. Analyze observations identified and generate effective responses. Maintain associated QM system documentation. Assist with maintaining the Regulatory Inspection Library and the continued enhancement of the inspection process. Assist with the development of tools to support inspection execution. Work collaboratively with all departments to assess, investigate, and manage potential serious breaches of GCP as reported in the QMS. Ensure responses for regulatory inspections and inquiries, ISO audit responses, and external audit responses (when requested) meet Clario, regulatory, and industry standards. This remote-based position may require infrequent visits to company offices or other locations to attend meetings or inspection support activities. OTHER DUTIES AND RESPONSIBILITIES: 1. Manage Issue Review Meetings as part of the Continuous Improvement Process and CAPA management. 2. Provide consulting services to contracted external sources as required. 3. Other related duties and projects as assigned. The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. CLARIO reserves the right to amend or change this job description to meet the needs of CLARIO. This job description and any attachments do not constitute or represent a contract.



