"Hello LinkedIn community! 👋
I have completed my MS in Drug Regulatory Affairs and I'm actively seeking new opportunities in the fields of Quality Assurance and Regulatory Affairs. I'm passionate about ensuring product quality and compliance and I am eager to contribute my skills to a dynamic team. If you know of any exciting opportunities or would like to connect, please feel free to reach out. Additionally, please feel free to share my profile with hiring managers. Let's explore possibilities together! 🌟 #QualityAssurance#RegulatoryAffairs#JobSeeker"
Making 10-minute deliveries happen (faster than your coffee brews) | Ex-Q-Commerce Europe | Last-Mile Ops, Dark Stores & P&L Leadership | Logistics & Supply Chain | Turning Delays Into Deliveries Since 2021
Is Regulatory Affairs the Career for You?
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Ceren's post is thought-provoking and sparked some reflections of mine.
Which teams do I engage with the most in my current role?
As a global RA, except for the routine registration processes, I have met specific challenges in global projects.
1. regulatory gaps - BD, R&D, QA and QC, Plasma Management Centre (PMC).
* Despite the strict regulatory environment for medicines in China, Chinese regulations are not widely recognized globally. Some regulations are unique and differ significantly from widely accepted authorities like the EMA and FDA, leading to a series of regulatory reforms in export projects. Beyond collaborating with the Quality departments and negotiating with foreign distributors, I have engaged from the very start of a product's life - the R&D stage - to develop strategies that mitigate potential regulatory gaps in future global projects.
* Notably, this kind of issue will be alleviated with the release of the 2025 version of the Chinese Pharmacopoeia (ChP), which aligns more closely with the EP, significantly simplifying the export of medicines to China. Additionally, with the government’s recent efforts on globalization and the high demand driven by China's large population, the Chinese healthcare market has big potential.
2. Coordination for GMP inspection/audit - Manufacturing, Quality
* While China's cGMP is heavily aligned with EU GMP - especially in Annex 1 for sterile products - passing inspection/audit from local authorities is still required in most export projects. This leads to personnel assignments and potential GMP corrections according to local regulations, although exemptions can be negotiated in certain cases.
3. Supply - BD, Manufacturing
* Certain plasma products are in high demand in domestic market due to the shortage of source plasma and manufacturing process constraints. Timely communication with both BD and Manufacturing departments is critical.
—————————————————————
RA is a role far beyond dossier preparation and submission. Regulatory intelligence spans the entire lifecycle of a product and serves a critical function in shaping platform knowledge.
Through deeper and more frequent cross-departmental collaboration, I am grateful for the opportunity to learn how different teams contribute to the journey of a product to patients. Meanwhile, through the increased involvement and collaboration with CMC teams, I have come to realize that regulatory compliance is not just a matter of documentation, but also a critical component of quality assurance in actual manufacturing process.
PRRC | Regulatory Affairs | In Vitro Diagnostic Medical Devices
I was once asked in a job interview why I like Regulatory Affairs.
Honestly, I wasn’t prepared for the question.
So, I paused and said the first thing that came to my mind.
I like it because I’m at the center of the whole process of getting a product to market. This role helps me understand how every department contributes to the process.
My interviewer smiled and agreed, saying that’s exactly why they like it too.
So, I got the job 🙂
But that’s not the point of this post. The real focus here is why Regulatory Affairs is so central to the operation.
The answer is simple, we provide guidance for every department.
Below, I’ll share some of the departments I regularly worked with and the kinds of conversations we had.
• 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗠𝗖: My core team that enabled me to submit applications (new marketing authorization or variation packages).
• 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 department is responsible for monitoring the safety of medicines. Once a need occurs to change product information, RA managers ensure submission of safety-relevant variations by following very strict authority deadlines.
• 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 is a window to customers and licensors. I could get involved in the process of in-licensing and out-licensing very early on.
• 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 & 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲: As part of the Quality management system, I was involved in the Change Management since I had to manage the life-cycle of my product portfolio.
• 𝗦𝘂𝗽𝗽𝗹𝘆 𝗖𝗵𝗮𝗶𝗻: Without aligning with this team, it was mostly impossible to submit product information relevant changes.
• 𝗟𝗮𝘂𝗻𝗰𝗵 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: I was in constant contact to accomplish the target launch dates.
Who do you engage with most frequently in your daily work?
Regulatory affairs department is the link between the operation departments and the marketing, commercial bodies, ensuring the compliance with the guidelines set by various health authority.
Regulatory affairs person must understand, be in sync and get aligned with the operation departments (production, QA, QC, Supply chain & R&D) with all the changes and variation cycles in the product formula, while keeping an eye on the potentional impact of the marketing, launch of the product in the market with the agreement of both marketing and commercial teams.
It is easy to read the checklist of new dossier submission or variation and prepare the needed documents according to each health authority guidelines but it is challenging to have all the parties aligned, therefore, regulatory affairs executive should be aware of all impacts that may be arised throughout the process.
PRRC | Regulatory Affairs | In Vitro Diagnostic Medical Devices
I was once asked in a job interview why I like Regulatory Affairs.
Honestly, I wasn’t prepared for the question.
So, I paused and said the first thing that came to my mind.
I like it because I’m at the center of the whole process of getting a product to market. This role helps me understand how every department contributes to the process.
My interviewer smiled and agreed, saying that’s exactly why they like it too.
So, I got the job 🙂
But that’s not the point of this post. The real focus here is why Regulatory Affairs is so central to the operation.
The answer is simple, we provide guidance for every department.
Below, I’ll share some of the departments I regularly worked with and the kinds of conversations we had.
• 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗠𝗖: My core team that enabled me to submit applications (new marketing authorization or variation packages).
• 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 department is responsible for monitoring the safety of medicines. Once a need occurs to change product information, RA managers ensure submission of safety-relevant variations by following very strict authority deadlines.
• 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 is a window to customers and licensors. I could get involved in the process of in-licensing and out-licensing very early on.
• 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗼𝗻𝘁𝗿𝗼𝗹 & 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲: As part of the Quality management system, I was involved in the Change Management since I had to manage the life-cycle of my product portfolio.
• 𝗦𝘂𝗽𝗽𝗹𝘆 𝗖𝗵𝗮𝗶𝗻: Without aligning with this team, it was mostly impossible to submit product information relevant changes.
• 𝗟𝗮𝘂𝗻𝗰𝗵 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: I was in constant contact to accomplish the target launch dates.
Who do you engage with most frequently in your daily work?
**"Are you considering a career in Regulatory Affairs? Or are you already in the field but looking to level up your skills? 🌐💼 Understanding the difference between RAC and RAP is key to navigating your career path effectively!
🔑 RAC (Regulatory Affairs Certification) is a globally recognized certification that sets you apart in a competitive industry. It’s ideal for those with experience who want to elevate their career with a formal acknowledgment of expertise in navigating regulatory landscapes. 🌍📜
🔑 RAP (Regulatory Affairs Professional) is often a title for professionals already working in the regulatory space, but it can also reflect various levels of experience. Whether you're a beginner or seasoned pro, the term represents your role in the field of regulatory affairs. 🌟👩🔬
For students, job seekers, and working professionals, these credentials and titles open doors to new opportunities and career advancement, ensuring you stay ahead in an ever-evolving industry. 🚀
Take the step toward advancing your regulatory affairs knowledge and career today! 🚀💡
Looking for Regulatory Affairs training call us on +919848733309 or Visit: https://lnkd.in/gTcfUxgr#RegulatoryAffairs#RAC#RAP#CareerDevelopment#ProfessionalCertification#JobSeekers#RegulatoryProfessionals#PharmaCareers#MedTech#GlobalCompliance#CareerGrowth"
MBA l B.Pharm(Gold Medalist)l Compliance l Regulatory Intelligence & Consulting l Quality Assurance l Risk Management l GxP l Quality Review l Internal Audits l Regulatory Affairs lCMC l Project Management l AI Prompting
From Quality Assurance to Regulatory Consulting: A Journey of Precision and Compliance
As someone who spent majority of experience in the Quality Assurance department of a pharmaceutical manufacturing company 🏭, I’ve come to truly appreciate the importance of compliance, precision, and attention to detail. These core values, which are the backbone of any QA role, have seamlessly translated into my current work in regulatory consulting 📑💼.
In QA, I was responsible for ensuring that every product met the highest standards✅, adhering to stringent regulations and quality protocols. This experience honed my ability to:
- Interpret regulatory guidelines effectively 📋
- Maintain meticulous documentation 📝
- Collaborate across teams 🤝 to ensure compliance
- Problem-solve under tight deadlines ⏳
Now, in regulatory consulting, these skills are even more critical. Whether it's navigating complex regulatory landscapes 🌍 or ensuring that clients meet the necessary compliance requirements, my background in QA gives me a unique edge 🏆.
The shift from QA to regulatory consulting has been both challenging and rewarding, but it has also shown me how interlinked these two fields are. Understanding the intricacies of quality processes has allowed me to offer more comprehensive, practical solutions to clients navigating global regulatory requirements 🌐.
Looking forward to sharing more insights from my journey! Would love to hear your thoughts on how Quality Assurance has influenced your career path.
#RegulatoryConsulting#QualityAssurance#Pharmaceuticals#Compliance#CareerJourney
Speaking from experience, I did not know it was a job until I was offered one! This option was never discussed whilst I was at university. I am very thankful to the people who introduced me to the fascinating world of regulatory affairs. As a regulatory toxicologist, the work we do is meaningful and has a positive impact on society!
#healthsciences#regulatorytoxicolgoy
💊 QA vs QC vs Pharmacovigilance: Key Differences & Career Insights
The pharmaceutical industry offers exciting opportunities for those looking to make a mark in Quality Assurance (QA), Quality Control (QC), or Pharmacovigilance (PV). While these roles share a common goal of ensuring drug safety and effectiveness, their approaches and responsibilities differ significantly.
🔍 What Does Each Role Entail?
Quality Assurance (QA):
🛡️ Focus: Ensuring processes comply with regulatory guidelines.
👉 Develops SOPs and quality systems.
👉 Conducts audits and ensures documentation accuracy.
👉 Works to prevent errors in processes.
Quality Control (QC):
🔬 Focus: Testing and verifying the quality of products.
👉Performs analytical testing on raw materials and finished goods.
👉Conducts stability studies and checks batch consistency.
👉Detects and corrects errors before release.
Pharmacovigilance (PV):
🩺 Focus: Monitoring drug safety after market release.
👉Reports adverse drug reactions (ADRs).
👉Works with regulatory authorities to ensure patient safety.
👉Focuses on public health by assessing post-marketing risks.
🌟 Career Opportunities & Growth
QA:
👉High demand in manufacturing and compliance roles.
👉Growth Path: QA Analyst → QA Manager → Head of QA.
QC:
👉Crucial for ensuring product quality in R&D labs and manufacturing.
👉Growth Path: QC Chemist → QC Manager → Analytical Head.
PV:
👉Growing field in clinical research organizations (CROs) and regulatory roles.
👉Growth Path: Drug Safety Associate → PV Manager → PV Director.
💼 Choosing the Right Path
Each role comes with unique challenges and rewards:
👉QA professionals ensure the process works perfectly.
👉QC experts are the guardians of product quality.
👉PV specialists are the champions of patient safety.
If you're analytical, detail-oriented, and driven to make a difference in healthcare, the Indian pharma industry is your playground. 🌍
📢 Call to Action
Explore these career paths and be a part of an industry that transforms lives daily. Which role excites you the most? Let’s discuss your thoughts below!
#PharmaCareers#QualityAssurance#QualityControl#Pharmacovigilance#IndianPharma#HealthcareInnovation#CareerOpportunities
🔍 Opportunities in Quality Control 🔍
The demand for quality control professionals in biotech and pharmaceuticals is on the rise! As companies strive to meet rigorous regulatory standards and ensure the highest product quality, the role of QC teams is more critical than ever.
At Viltis, we recognize the importance of maintaining excellence in quality, clinical, and regulatory areas. Whether you’re a seasoned QC expert or just starting your career, now is an exciting time to explore opportunities in this field.
Check out this article from BioSpace highlighting 9 companies currently hiring for quality control positions: https://lnkd.in/gmJmMvpe
As always, Viltis is here to support your journey in Quality, Clinical, Regulatory, Engineering, and Scientific areas. Let's work together to push the boundaries of what's possible in healthcare!
#QualityControl#BiotechCareers#Viltis#HealthcareInnovation#QualityAssurance#RegulatoryAffairs
Customer Success Manager| Project Management | Clinical Operations | Trial Master File | Customer Relationships Management (CRM)
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