Regulatory Affairs Post-Approval Associate-Europe - DEMO Global Services Center
At Demo SA, one of the world’s largest pharmaceutical manufacturers in injectable facilities, we are looking for a talented Regulatory Affairs Associate to join our team. The job responsibilities for this position includes post-marketing regulatory submissions for Europe and other global markets for sterile, non-sterile and oral solid/liquid products. This position is based at Hyderabad, India.
Responsibilities:
- Understanding of Regulatory strategy and documentation requirements for EU variations including renewals, extensions for Sterile (SVP, LVP, lyophilized, ophthalmic etc.), non-sterile and oral solid/liquid products.
- Collect, prepare, compile regulatory documentation, for the product’s lifecycle maintenance (administrative, quality, safety variations and renewal procedures).
- Prepare and coordinate responses to Deficiency Letters (DLs) and other CMC-related regulatory queries in collaboration with cross-functional teams
- Preparation of module 1 documentation for as per assigned timelines for out-licensing and in-licensing products in EU countries
- Liaise with various departments to collect all necessary information and documentation, in accordance with defined guidelines for Pharmaceutical Dossier submission and product registration
- Liaise with external Regulatory authorities as required
- Act as responsible Regulatory Team member for assigned regulatory projects
- Support internal activities of Regulatory department in order to ensure regulatory compliance of registered products
- Bachelor or Master Degree in Pharmacy with 3+ years of experience in Regulatory Affairs / CMC within a Pharmaceutical organization.
- Knowledge of CMC and global regulatory guidelines for Sterile (small & large volume parenteral, aqueous solution, lyophilized product, sterile powder etc) and oral solid/liquid dosage form.
- Strong organization skills, multi-tasking and able to meet deadlines.
- Effective communication and relationship management.
- Ability to work under pressure, resilience.
The company offers competitive salary and benefits, continuous specialized training, career development and a friendly working environment.
Similar roles
Mechatroniker / Elektroniker für Betriebstechnik (w/m/d)
Apleona GmbH·Stuttgart, Germany
Unsere Teams im Gebäudebetrieb und der Haustechnik sorgen dafür, dass alle technischen Anlagen reibungslos funktionieren und Gebäude optimal instand gehalten werden. Ob Wartung, Reparatur oder technisches Facility Management – wir gewährleisten eine sichere und effiziente Umgebung für Mitarbeiter, Kunden und Besucher. Sie haben technisches Geschick, eine lösungsorientierte Arbeitsweise und Freude daran, Gebäude am Laufen zu halten? Dann freuen wir uns…
- Full-time
- Blue Card — tied; settle 21–33mo
Technical Project Manager
Runmap Infotech Private Ltd.·Mumbai, India
Hiring: Technical Project Manager | 7 Years | Immediate Opportunity We are looking for an experienced Technical Project Manager with a strong software development background to drive end-to-end technical project delivery. Experience: 7 Years Development Experience: Minimum 5 Years Qualification: B.Tech/B.E. – CS/IT/ECE or related field Key Skills • Technical Project Management & Development Team Management • End-to-end application delivery…
- Full-time
Data Center Infrastructure Specialist
Nvidia·Australia
NVIDIA is looking for a Data Center Deployment Specialist to join its Professional Services team. Academic and commercial groups around the world are using NVIDIA products to revolutionize deep learning and data analytics, and to power data centers. Join the team building many of the largest and fastest data centers in the world! NVIDIA is looking for someone with the…
- Full-time
- Skilled Independent 189 — PR, no sponsor
Software Engineering
intrinsicrobotics·Mountain View, United States
<div class="content-intro"><p><span style="font-weight: 400;">Intrinsic is an AI robotics group at Google aiming to reimagine the potential of industrial robotics. Our team believes that advances in AI, perception and simulation will redefine what’s possible for industrial robotics in the near future – with software and data at the core.</span></p> <p><span style="font-weight: 400;">Our mission is to make industrial robotics intelligent, accessible, and…
- On-site
- Full-time
Private Events Server - JOEY King Street
JOEY Restaurants·Toronto, Canada
This is about you. Your passion, purpose and potential. In you, we see care, drive, confidence and curiosity. When you join our team, you can expect intensity, excitement and energy. Through our culture of people development, we are committed to the continuous learning and growth of our teams. As a Private Events Server, you'll help create exceptional experiences for guests…
- Full-time
- Express Entry — PR day one, no employer
Senior Manager, Corporate Strategy
Freshworks·San Mateo, United States
Freshworks is looking for a Senior Manager to join our global Corporate Strategy team and help shape some of the most important decisions facing the company. This is a high-impact strategy role for someone who loves solving complex business problems but wants to get closer to the decisions, the executives making them, and the outcomes that follow. You'll work directly…
- Hybrid
- Full-time
Partner Director, PwC
Openai·San Francisco, United States
About the Team OpenAI’s GTM Partnerships team builds a strategic, global partner ecosystem to accelerate customer success, enable responsible enterprise AI adoption, and drive durable growth in support of OpenAI’s mission. We work cross-functionally across Sales, Solutions, Product, Engineering, Security, Legal, Finance, Marketing, Operations, and Customer Success to translate strategic partnerships into measurable outcomes for customers. Global consulting and advisory…
- On-site
- Full-time
Fixed Income & Investment Research Expert - AI Training & Evaluation
Volga Partners·India
Location: Pakistan or India (Remote) Compensation: $5.00–$9.00 USD per hour (depending on experience and qualifications) We are particularly interested in professionals with experience in valuation, financial modeling, M&A, capital markets, and corporate finance. HELP SHAPE THE FUTURE OF AI IN FINANCE Volga Partners is seeking experienced finance professionals to join a specialized AI initiative supporting the development, training, and evaluation…
- Remote
- Part-time
