Regulatory Affairs Senior Associate (Amgen, Hyderabad)

Amgen's Regulatory Affairs Senior Associate Role in Hyderabad! 🚀

Are you ready to be at the forefront of medical innovation, shaping how life-changing medicines reach patients worldwide? Do you thrive in a dynamic, fast-paced environment where your precision and expertise make a tangible difference? If so, then Amgen's Regulatory Affairs Senior Associate position in Hyderabad, India, might just be your next big career leap! 🌟

This isn't just a job; it's an opportunity to join a global biotechnology powerhouse, a company that has been a pioneer in its field for over four decades, consistently pushing the boundaries of what's possible in healthcare. Let's unwrap what makes this role so exciting and why you should consider making Amgen your next professional home.

Amgen: A Legacy of Innovation & Impact 🧬

Imagine working for a company that harnesses the very best of biology and technology to tackle some of the world's most formidable diseases. That's Amgen for you! Since its inception more than 40 years ago, Amgen has been on a relentless quest to discover, develop, manufacture, and deliver innovative medicines that genuinely transform lives. Their mission is clear: to help millions of patients live easier, fuller, and longer lives. By leveraging cutting-edge technology and human genetic data, Amgen is not just keeping pace with scientific advancements; they are actively defining the future of biotechnology.

When you join Amgen, you become part of a legacy of scientific excellence and a culture that values innovation, collaboration, and a deep commitment to patients. It's a place where your work contributes to a grander purpose, making a real-world impact. Think about the satisfaction of knowing that your diligent efforts in regulatory affairs directly contribute to bringing vital treatments to those who need them most. 🙏

The Heart of the Matter: Your Role as a Regulatory Affairs Senior Associate 🎯

So, what exactly does a Regulatory Affairs Senior Associate do at Amgen? This isn't a back-office, behind-the-scenes kind of role. This position is central to ensuring that Amgen's groundbreaking medicines comply with stringent US regulatory standards, particularly concerning promotional materials. You'll be a vital cog in the machine that brings critical information about these medicines to healthcare providers and patients.

Operating from the vibrant city of Hyderabad, this is an On-Site, Full-Time position. You'll be assisting US Promotion Regulatory representatives and a myriad of cross-functional teams in steering regulatory strategies for departmental initiatives across all product brands. This means you'll have a broad impact, touching various aspects of Amgen's diverse portfolio.

Your day-to-day responsibilities will be multifaceted and dynamic, covering a spectrum of critical tasks:

 * Documentation Mastery: You'll be instrumental in preparing, meticulously tracking, generating reports on, and diligently archiving US regulatory documentation. This includes preclearance and advisory comment promotional materials, ensuring everything is accounted for and readily accessible. Think of yourself as the guardian of crucial regulatory information! 📚

 * Ad/Promo Data Management: This is where your organizational prowess truly shines! You'll be solely responsible for all Ad/Promo (Advertisement/Promotional) regulated data management. This involves a keen eye for detail and a systematic approach to handling large volumes of critical information. 📊

 * Label Change Orchestration: The role involves meticulous planning and tracking of all US promotional label changes. This isn't just about updating text; it's about managing the entire system update process for promotional labeling and, crucially, Important Safety Information (ISI). Your precision here directly impacts patient safety. 🔄

 * Digital Labeling & Performance Tracking: You'll oversee US digital labeling, ensuring accuracy and compliance in the digital realm. Furthermore, you'll track team performance and identify savings opportunities related to label change implementation. This adds a strategic dimension to your role, contributing to efficiency and cost-effectiveness. 💻

 * Core Operational Responsibilities:

   * Label change updates and implementation process: Ensuring seamless transitions for updated product information.

   * Logo & Package Component Labeling (PCL) changes: Managing the visual and textual elements of product packaging.

   * Important Safety Information (ISI) updates: A critical task ensuring that safety information is always current and accessible.

   * Product shot index management of drug product imagery: Maintaining a precise record of all drug product visuals.

   * Label change content assessment binders: Compiling and organizing comprehensive binders for assessment.

   * System workflow assessments of label impacted promotional material: Analyzing and optimizing workflows for promotional materials affected by label changes.

   * Regulatory Information Management (RIM) archiving: Meticulously archiving crucial regulatory information.

   * Preclearance & Request for Advisory Comments (RFAC) submissions: Handling the formal submission process for promotional materials.

   * Reporting/Archiving of Ad/Promo FDA Communications: Managing official communications from the FDA, including Intent to Comply, Record of Contact (ROC), Prescription Drug Marketing Act (PDMA), and Dear Healthcare Provider (DHCP) letters.

   * Veeva data entry/retrieval and collection of information: Leveraging Veeva for efficient data management.

   * Process documentation authoring support: Contributing to the creation and maintenance of clear, concise process documents. 📝

What Amgen is Looking For: Your Core Strengths 💪

To excel in this role, Amgen is seeking individuals who embody a specific blend of professional attributes and technical proficiencies.

Required Knowledge and Skills:

 * Professionalism & Relationships: You must exhibit a professional demeanor in all interactions, consistently fostering constructive working relationships with colleagues, superiors, and external stakeholders. Collaboration is key in the world of regulatory affairs! 🤝

 * Communication Prowess: Excellent verbal and written communication skills are non-negotiable. You'll be articulating complex regulatory information, so clarity and precision are paramount. 🗣️✍️

 * Reliability & Diligence: Amgen values individuals who are dependable, complete their work accurately, thoroughly, and on time, and approach assignments with a strong sense of conscientiousness. Your meticulousness will be your superpower! ✨

 * Instruction Adherence: The ability to comprehend and follow written instructions and documented processes is fundamental. Regulatory affairs is built on adherence to guidelines. 📖

 * Meeting Management: You should be adept at leading and managing video conference meetings (e.g., using MS Teams) and providing accurate meeting minutes. Efficient collaboration is vital. 🖥️

 * Microsoft Office Suite Mastery: Proficiency in MS Word, Excel, PowerPoint, and Visio is essential. Crucially, you must be able to manipulate data using formulas in Excel spreadsheets, including pivot tables – your data analysis skills will be put to good use! 📊

 * Technical Editing & Presentation: Strong technical editing and proofreading skills are required for process documents. The ability to create compelling infographics and slides will also set you apart. 🎨

 * Veeva PromoMats Expertise: Extensive experience in Veeva PromoMats is a must, specifically for creating Electronic Common Technical Documents (eCTD) compliance packages for US FDA submissions. A strong understanding of FDA eCTD publishing tools is critical. 💻

 * US MLR Review Process: Knowledge and experience in the US Medical, Legal, and Regulatory (MLR) review process within Veeva PromoMats to complete Abbreviated Reviews is highly valued. You'll be navigating this crucial review pathway. ✅

 * Veeva RIM Vault Proficiency: Expertise in the Veeva Records Information Management (RIM) Vault for archiving and maintaining compliant US Health Authority records is a key requirement. Data integrity and accessibility are paramount. 🗄️

 * MS SharePoint/Teams Collaboration: Proficiency in MS SharePoint/Teams for collaboration and managing department records/process documentation demonstrates your ability to work efficiently within Amgen's digital ecosystem. 🌐

 * MS Outlook Inbox Management: Excellent organizational skills for MS Outlook, including creating email rules and standard email templates, will ensure your communication is streamlined and efficient. 📧

Preferred Knowledge and Skills (Skills that will make you stand out!):

 * Biopharmaceutical Experience: Prior experience with US Regulatory Advertisement/Promotional (Ad/Promo) expertise, especially within Amgen or another biopharmaceutical company, is a significant plus. This demonstrates your industry-specific knowledge. 🌟

 * SharePoint Navigation & Maintenance: Previous experience navigating and maintaining document records within SharePoint will be highly advantageous.

 * Veeva Business Admin Certification: Being Veeva Business Admin certified (PromoMats & RIM) showcases a deeper level of expertise and dedication. 🏆

 * US Regulatory Ad/Promo Project Management: Experience in project management within US Regulatory Ad/Promo, coupled with a strong knowledge of FDA promotional regulations, highlights your strategic capabilities. 📈

 * US Labeling & Document Management: Experience in US labeling, regulatory document management, and promotional review and approval processes demonstrates a comprehensive understanding of the regulatory lifecycle. 🔄

Your Background: Education & Experience 🎓

Amgen values both academic achievement and practical experience. Here's what they are looking for:

Basic Education and Experience:

 * Master’s degree and 4 years of related experience, OR

 * Bachelor’s degree and 6 years of related experience

Preferred Education and Experience (These will give you an edge!):

 * Bachelor’s degree and 6 years of related experience (Note: this is listed as preferred, indicating a strong preference for this combination).

 * Experience working in a Global Regulatory Affairs organization will be highly regarded, showcasing your ability to navigate complex international regulatory landscapes. 🌍

Why Hyderabad? 🇮🇳

Choosing Hyderabad as your professional base offers a fantastic blend of career opportunities and quality of life. Known as a burgeoning hub for the pharmaceutical and biotechnology industries, Hyderabad provides a dynamic ecosystem for professionals in this field. Beyond work, the city boasts a rich cultural heritage, delicious cuisine, and a vibrant, modern lifestyle. It's a city that balances tradition with innovation, offering something for everyone. 🌆

Your Next Step: Seize the Opportunity! 🚀

If you've read through this and feel a surge of excitement, if your skills align with Amgen's needs, and if you're eager to contribute to a company that's truly changing the world, then don't hesitate! This "Regulatory Affairs Senior Associate" role at Amgen is a fantastic opportunity to advance your career, work with cutting-edge technology, and be part of a team dedicated to making a profound impact on patient lives.

Apply now and embark on a rewarding journey with Amgen – where innovation meets purpose! Your future in regulatory affairs awaits. Good luck! ✨

Apply here