Health Plan of San Joaquin/Mountain Valley Health Plan’s Post

💼 Are you looking to make a career change while staying in the familiar field of licensing and professional regulation? Your professional experiences and skillset in the regulatory sector can be easily transferred, opening up a wide range of employment opportunities that align with your goals. Discover the various opportunities available by visiting RegulatoryJobs.org. #professional #licensing #regulation #jobs #careers #change #consumerprotection #impact

𝐓𝐡𝐞 𝐡𝐨𝐥𝐲 𝐭𝐫𝐢𝐧𝐢𝐭𝐲 𝐨𝐟 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐲 During my >25 year career, I’ve come across two major hiring horrors: 🙊 A SVP of Global Regulatory Affairs who had previously worked at a biologics company where the CEO had been convicted of insider trader dealing for off-loading his shares on the expectation that FDA was going to reject their BLA application. Although the SVP sold sizeable amounts of stock, they were never charged! 🙈 An EU Head of Regulatory Affairs who had a fake academic qualification. If this wasn’t alarming enough: 😱 The SVP hired the EU Head of Regulatory Affairs and created a culture of fear, gaslighting, bullying and sabotage. 😬 It was affecting some of the regulatory interactions and strategy. 😷Regardless, the company was successful and delivering value to its shareholders. 🕵♀️ I discovered these hiring blunders by performing my own due diligence and yet these were missed! 𝑰𝒇 𝒚𝒐𝒖 𝒅𝒊𝒗𝒐𝒓𝒄𝒆 𝒑𝒆𝒐𝒑𝒍𝒆 𝒂𝒏𝒅 𝒐𝒓𝒈𝒂𝒏𝒊𝒔𝒂𝒕𝒊𝒐𝒏𝒔 𝒇𝒓𝒐𝒎 𝒓𝒆𝒈𝒖𝒍𝒂𝒕𝒐𝒓𝒚 𝒔𝒕𝒓𝒂𝒕𝒆𝒈𝒚, 𝒚𝒐𝒖 𝒅𝒐 𝒔𝒐 𝒂𝒕 𝒚𝒐𝒖𝒓 𝒐𝒘𝒏 𝒓𝒊𝒔𝒌! 🌱 On what terms do your organisation to be successful? ⛔ What are your non-negotiables in terms of values and behaviours? 🤔 How well do you 𝑟𝑒𝑎𝑙𝑙𝑦 know what’s going on in your business? #values #companyculture #management #recruitment #biotech #regulatoryaffairs

Good opportunity in Regulatory role

In the high-stakes world of #regulatoryaffairs, where precision meets policy, the question isn't just "What job do I want?" but rather "What impact do I want to make?" Think about it. As Regulatory professionals, you're not just checking boxes or filling out forms. You're guiding innovations safely to market. You're protecting the public. You're shaping the future of healthcare, technology, and industry. 💡 But here's the catch: Not all opportunities are created equal. So how do you choose the RIGHT team and organization that aligns with your vision and values? 🎯 Are you seeking a team that's at the forefront of emerging regulations, not just complying with existing ones? 🎯 Is the organization's commitment to ethics, quality, and public safety in harmony with your professional creed? 🎯 What avenues for personal growth and professional development are specifically tailored to the evolving landscape of regulatory affairs? These are questions only YOU can answer, but they're worth pondering. Because, in Regulatory Affairs, your choice is more than just a career move... If you're a Reg Affairs pro aiming to align your career with your purpose, hit the 'Like' button, share your insights below, or tag a colleague who needs to see this!

Quality management is especially well suited for fractional leadership. Why? 1. **Expertise and Efficiency**: Quality management requires specialized knowledge and skills to effectively implement and sustain quality standards, such as ISO certifications or Six Sigma methodologies. Fractional leadership allows organizations to hire seasoned executives with specific expertise in quality management for a fraction of the time and cost of a full-time position. This provides access to high-level skills that might otherwise be unaffordable. 2. **Flexibility**: Quality management often involves project-based work, such as setting up a new quality system, training staff, or leading specific quality improvement initiatives. Fractional leaders can work flexibly, scaling their involvement up or down depending on the phase of the project or the current needs of the organization. This adaptability is particularly useful in quality management, where the intensity of the need for leadership can vary. 3. **Objective Perspective**: Fractional leaders are not bogged down by the company's internal politics or past history. This allows them to provide a fresh, unbiased perspective on quality issues, which is crucial for effective problem-solving and innovation in quality management practices. They can challenge the status quo and drive changes that internal leaders might be hesitant to implement. 4. **Cost-Effectiveness**: Employing a fractional leader for quality management is cost-effective because it avoids the full expense of a full-time salary, benefits, and other employment costs. Companies can invest these savings into other critical areas, like process improvements or technology upgrades, which directly benefit quality outcomes. 5. **Strategic Focus**: Fractional leaders typically work with multiple organizations and thus bring a wealth of industry knowledge and best practices. This experience enables them to focus strategically on what really works in quality management across different contexts, tailoring their approach to the specific needs and culture of each organization they work with. 6. **Scalability**: As organizations grow, their quality management needs can become more complex. Fractional leadership can adapt to these changing needs, providing more intensive guidance during periods of rapid growth or major change, and stepping back when processes are running smoothly. #medicaldevices #qualityassurance

When speaking to clients, I've found that thriving in the changing scientific regulatory landscape has proven difficult for a number of businesses recently. Here's a few points on why a strong Regulatory Affairs team is essential: 🧭 In navigating complex regulations, a proficient team can help identify pathways that align your product or service with stringent regulatory frameworks. This saves you from costly compliance missteps later down the line. I often see smaller businesses neglecting Regulatory Affairs, but hiring an in-house professional can streamline and accelerate your success early. 💼 Think of them as strategic and academic partners! Their insights and knowledge into regulatory trends help you to break into new markets and cross global borders. They decrypt worldwide legislation and execute complex regulatory submissions, leading to new market access for your business. 🤝 They really are the glue that hold your team together. As liaisons between departments, they create, compile and review numerous technical elements for each team, and ensure that safety and efficacy is maintained. #RegulatoryAffairs #ComplianceMatters #InnovationGovernance

For those interested

For those interested in developing yourselves or your team members, there are excellent insights in the video below, which featured Jill Dailey, Jake DeBoever, and Jeffrey Kawalek. I'm happy to share the slides and additional handouts if you're interested.

The hiring budget is frozen, your best regulatory specialist just gave notice, and you've been tasked with bringing five new products to market in 2024.    How are you going to manage? 😳 Hint: startups do it all the time. They hire senior executives to fulfill C-Suite roles for a fraction of the time and expense they would incur if hiring someone full time.   Fractional leadership has helped thousands of startups achieve their business goals without decimating their budgets. Imagine what fractional quality assurance services could do for you.   Need a detailed CER to complete your MDR application? We can do that. Quality management system a shambles? We can fix it. Still not clear as to what is in a Design History File? We can help.   And if you're looking for a qualified Person Responsible for Regulatory Compliance (PRRC), well, we can do that, too.   For the love of regulatory science, don't wait any longer.  Put some time on our calendar and we'll talk. #medicaldevices #regulatoryaffairs #compliance #FDA #PRRC #qualitymanagement #eumdr

🌟 Exciting Career Update! 🌟 Thrilled to share that I've shifted my focus to specialise in the Regulatory and Compliance sector here at William Rose Associates! 🚀 Are you passionate about regulatory affairs? Let's connect! Whether you're navigating compliance challenges or seeking talent in this dynamic field, I'm here to collaborate and support your goals. Looking forward to connecting with industry professionals interested in regulatory and compliance opportunities! #RegulatoryCompliance #CareerTransition #WilliamRoseAssociates #LetsConnect #regulatoryjobs #compliancejobs #financialjobs