Regulatory Affairs Jobs | Lonza is Hiring | Apply Now
Looking for high-growth Regulatory Affairs Jobs in the pharmaceutical and biotechnology industry? Lonza is hiring Regulatory Affairs Specialists in Hyderabad for its Global Capability Center (GCC). This opportunity is ideal for candidates searching for Lonza Careers and Life Sciences Jobs with experience or interest in CMC documentation, regulatory submissions, Veeva Vault, eCTD publishing, and clinical trial application support.
- Job Title: Regulatory Affairs Specialist
- Location: Hyderabad, India
About the Company
Lonza is a globally recognized pharmaceutical and biotechnology manufacturing company with more than 30 sites across five continents. The company supports the development and manufacturing of innovative therapies and medicines worldwide. Lonza is known for its collaborative culture, regulatory expertise, and commitment to advancing life sciences and healthcare innovation.
Key Responsibilities
- Support the site and customer-related regulatory dossier activities for clinical trial applications.
- Write CMC regulatory dossiers using source documents, ensuring accuracy, completeness, and compliance.
- Support product lifecycle management activities.
- Manage regulatory workflows, trackers, and document systems (e.g., Veeva) to ensure timely and controlled submissions.
- Collaborate with Lonza network Regulatory teams to coordinate the regulatory submissions to achieve successful submission outcomes.
Education
Degree in Biology, or related Life Sciences discipline.
Skills Required
- Strong knowledge of global regulatory requirements and CMC documentation (clinical and commercial submissions).
- Experience with Veeva Vault, eCTD publishing, and document management systems.
- Strong project management skills with the ability to manage multiple priorities and timelines.
- Excellent communication skills with business fluency in English and the ability to influence stakeholders.
- Collaborative, proactive, and solution-oriented mindset with strong accountability and ownership.
For candidates searching for Regulatory Affairs Jobs, Lonza Careers, and Life Sciences Jobs, this opportunity offers excellent exposure to global pharmaceutical regulatory operations, CMC documentation, clinical submissions, and regulatory workflow management. Working with Lonza can help life science graduates build a strong career in regulatory affairs, pharmaceutical compliance, and biotechnology industries.
