Associate Regulatory Affairs (Amgen, Hyderabad)

Associate Regulatory Affairs in Amgen, Hyderabad! 🚀

Are you a wizard with digital assets, a master of meticulous detail, and passionate about ensuring groundbreaking medicines reach patients safely and effectively? Do you thrive in a fast-paced environment where your creativity meets compliance? Then prepare to be thrilled, because Amgen is seeking an exceptional Associate Regulatory Affairs professional to join their vibrant team in Hyderabad, India! 🌟

This isn't just another job posting; it's an invitation to become an integral part of a global biotechnology leader, a company that has been at the forefront of scientific innovation for over four decades. Amgen is not just making medicines; they're shaping the future of healthcare, and you could be a vital part of that journey.

Amgen: Pioneering Health, One Innovation at a Time 🔬

Imagine working for an organization that relentlessly pursues solutions to the world's toughest diseases. That's Amgen's daily mission. With a rich history spanning more than 40 years, Amgen has consistently harnessed the best of biology and technology to discover, develop, manufacture, and deliver innovative medicines that truly make a difference in millions of lives. They're not just keeping pace with scientific advancements; they're pushing beyond what's known today, leveraging cutting-edge technology and human genetic data to redefine possibilities in medicine.

Joining Amgen means becoming part of a community driven by a singular, powerful purpose: to make lives easier, fuller, and longer for patients worldwide. Your work will directly contribute to this noble cause, ensuring that vital treatments are disseminated with precision and integrity. It's a place where innovation, collaboration, and a profound commitment to patient well-being are not just buzzwords, but lived realities. 🙏

Your Mission: The Associate Regulatory Affairs Role Unveiled 🎯

As an Associate Regulatory Affairs professional at Amgen in Hyderabad, you’ll step into a multifaceted and highly impactful role. This On-Site, Full-Time position is far from a typical desk job. You will be a crucial link in the chain, ensuring the seamless flow of promotional materials while upholding the highest standards of regulatory compliance.

Your primary focus will be on the coordination and execution of FDA 2253 reporting submissions, a critical aspect of regulatory transparency. But your responsibilities extend far beyond that! You'll also take on the pivotal role of Amgen’s Digital Asset Management (DAM) librarian, becoming the go-to expert for all things related to digital content. Furthermore, you'll provide essential administrative support to Operations staff throughout various project lifecycles, especially during label changes.

This is a truly cross-functional position, meaning you'll be collaborating extensively. Get ready to engage closely with Regulatory Operations, interact with dynamic marketing teams, and work hand-in-hand with creative agencies to drive key commercial objectives. Your ability to bridge the gap between creative vision and regulatory requirements will be paramount.

A unique and exciting aspect of this role is the critical requirement for strong proficiency in graphic design and video editing software. Yes, you read that right! Tools like Adobe Creative Suite, Premiere Pro, and After Effects are not just a bonus; they are critical for your success in this position. If you have a flair for visual content and technical savvy, this role offers a thrilling blend of regulatory rigor and creative application. Proficiency with Veeva PromoMats is also highly preferred, underscoring the importance of digital content management.

Let's dive into the core responsibilities that will define your exciting days at Amgen:

 * FDA 2253 Reporting Submissions: You'll be at the helm, conducting quality assurance reviews and processing the daily release of FDA Form 2253 reportable submissions for promotional materials. This involves meticulous attention to detail to ensure accuracy and compliance. 📋

 * Creative File & Metadata Evaluation: You'll meticulously evaluate creative file submissions and system metadata of marketing materials. Your keen eye will ensure completeness, accuracy, and strict adherence to licensing requirements. Think of yourself as the gatekeeper of compliant content! 🧐

 * Digital Asset Management (DAM) Expertise:

   * Usage Rights Oversight: Collaborating with creative agencies and marketing teams, you'll oversee the renegotiation, renewal, and collection of usage rights for marketing materials. This ensures Amgen's promotional content is legally sound. ⚖️

   * Art Procurement Services: Leveraging company subscriptions, you'll provide crucial art procurement services to support Amgen’s marketing initiatives, helping bring their campaigns to life. 🖼️

   * Digital Asset Distribution: You'll retrieve, validate, and distribute digital asset packages to agencies and marketing teams, utilizing Amgen’s various data repositories. This ensures the right assets get to the right people, efficiently. 📤

   * Stakeholder Engagement: You'll facilitate and actively participate in stakeholder meetings, ensuring seamless adherence to Digital Asset Management (DAM) timelines and processes. Your communication skills will shine here! 💬

 * Record Management & System Proficiency: You’ll maintain and manage critical records in Veeva PromoMats, RIM (Regulatory Information Management), and SharePoint. If you have prior experience with SharePoint and Veeva Business Admin certification, you're already a step ahead! 🗄️

 * Meeting Facilitation & Documentation: You’ll lead and facilitate Webex/MS Teams meetings, taking charge of agenda preparation and ensuring accurate documentation of meeting minutes. Your organizational skills will be invaluable. ✍️

 * Creative & Technical Content Creation: You'll be creating compelling infographics and presentation materials. Additionally, you’ll perform technical editing and rigorous proofreading of process documentation, ensuring clarity and precision in all written communications. 🎨

What Amgen is Looking For: Your Essential Toolkit 🧰

To thrive in this dynamic role, Amgen seeks a professional with a robust set of skills and knowledge.

Required Knowledge and Skills:

 * Veeva PromoMats and RIM Expertise: This is non-negotiable! You must have hands-on experience navigating Veeva PromoMats and RIM platforms for managing promotional and medical content. A strong understanding of Veeva workflows (initiating, reviewing, approving, routing materials) is crucial. You'll also perform QC checks on materials to ensure compliance with US regulatory, legal, and brand standards, and maintain accurate metadata within these systems. 💻

 * Veeva DAM Proficiency: You'll be adept with Veeva's digital asset management (DAM) systems, comfortable handling various file types, metadata, licensing agreements, and usage rights. Familiarity with DAM best practices, including asset tagging, archiving, and retrieval within Veeva, SharePoint, and BOX, is essential. 📦

 * Regulatory Compliance Acumen: You must possess a solid understanding of compliance and US FDA regulatory requirements for promotional materials within the pharmaceutical or life sciences industry. Your knowledge here is key to patient safety and company integrity. ✅

 * Troubleshooting Skills: The ability to troubleshoot and resolve metadata or workflow issues, collaborating effectively with cross-functional teams (Regulatory, Marketing, Creative Agencies), demonstrates your problem-solving capabilities. 💡

 * Detail-Oriented Mindset: Your sharp eye for detail will be critical in identifying discrepancies and ensuring data integrity across documents and metadata fields. Precision is paramount! 🔍

 * Adaptability in a Regulated Environment: You should be comfortable navigating a fast-paced, highly regulated environment, adept at managing multiple tasks and priorities, and meeting tight deadlines. ⏱️

 * Strong Communication Skills: Effective communication is vital for liaising with stakeholders and providing clear guidance on Amgen’s Veeva PromoMats processes and best practices. 🗣️

 * eCTD & FDA Submissions: Experience in Veeva PromoMats to create Electronic Common Technical Documents (eCTD) compliance packages for US FDA 2253 submissions, coupled with strong knowledge of US FDA eCTD publishing tools, is a must. You should also be familiar with US FDA guidance for promotional material submissions. 📂

 * Adobe Creative Suite & Design Tools: This is a highlight of the role! Strong knowledge of Adobe Creative Suite (Photoshop, Illustrator, InDesign) and other design tools is required. This proficiency will be directly applied to your DAM librarian responsibilities. 🎨

 * Microsoft Office Suite Proficiency: You’ll be proficient in PowerPoint, Visio, Excel (including pivot tables), and Word. Your data analysis skills in Excel will be particularly valuable. 📊

 * Project Management Aptitude: A proven ability to manage multiple projects simultaneously while consistently meeting deadlines and adhering to established processes is essential. 🗓️

 * Outlook Management: Excellent MS Outlook inbox management skills, including creating email rules and standard email templates, will ensure efficient communication. 📧

 * Documentation & Reporting: You will develop and maintain clear, structured process documents, SOPs, and workflow guides. Additionally, you’ll design and run periodic and ad hoc reports using Veeva’s reporting functionality to support leadership in performance data analysis. 📈

Preferred Knowledge and Skills (Skills that will make you shine brighter! ✨):

 * Relevant Bachelor’s Degree: A Bachelor’s degree in graphic design, visual arts, marketing, or a related creative field will be a significant asset, reinforcing your creative background. 🎓

 * Industry Experience: A minimum of 2+ years of experience in marketing, pharmaceutical, or healthcare industries, coupled with a strong understanding of regulatory requirements for promotional materials, demonstrates invaluable industry context. 💡

 * Veeva Business Admin Certification: This certification indicates a deeper level of expertise and commitment to Veeva platforms. 🏆

 * Cross-functional Collaboration: Experience collaborating with creative agencies and cross-functional teams to facilitate the collection, transfer, and distribution of marketing materials is highly valued. 🤝

 * Exceptional Attention to Detail: An excellent eye for detail and the ability to conduct thorough quality control checks on creative files for promotional content is a huge plus. ✅

 * FDA Regulations Understanding: A strong understanding of FDA regulations and compliance requirements related to marketing materials and submissions will set you apart. 📖

 * Analytical & Problem-Solving Skills: Strong analytical and problem-solving skills for ensuring accuracy in digital asset retrieval, troubleshooting file issues, validation, and distribution are highly sought after. 🧠

 * Effective Communication & Stakeholder Management: Your ability to lead and participate in discussions regarding DAM timelines and creative file submission approvals will be a key differentiator. 🗣️

Hyderabad: Your New Professional Home 🏡

Choosing Hyderabad as your career destination means immersing yourself in a city that's rapidly emerging as a global hub for the pharmaceutical and biotechnology sectors. This thriving ecosystem offers unparalleled professional growth opportunities within a supportive and innovative environment. Beyond your career, Hyderabad promises a vibrant lifestyle – from its rich historical heritage and delectable cuisine to its modern infrastructure and diverse cultural experiences. It’s a city that effortlessly blends tradition with progress, offering a fulfilling personal and professional life. 🌆

Seize Your Moment! 🌟

If this description resonates with your skills, aspirations, and passion for making a tangible impact, then this is your moment! The "Associate Regulatory Affairs" role at Amgen in Hyderabad offers a unique blend of regulatory compliance, digital asset management, and creative application. It’s an opportunity to be part of a pioneering company that is genuinely transforming patient lives worldwide.

Don't just dream about a fulfilling career; make it a reality. Apply now and take the first step towards a rewarding future with Amgen – where your expertise empowers innovation, and every day brings new opportunities to contribute to a healthier world! Good luck! ✨

Apply here