Regulatory Affairs Senior Specialist
Location: Hyderabad, India (Hybrid)
Relocation assistance is available for eligible candidates and their families, if needed
Join Lonza’s Global Capability Center (GCC) in Hyderabad and play a key role in global regulatory submissions. As a Senior Specialist in Regulatory Affairs (CMC), you will lead dossier authoring across development and commercial programs for large and small molecule products.
What you will get
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Opportunities to collaborate with global cross-functional teams.
- Ongoing learning and professional development opportunities.
- Our full list of global advantages can be found here: https://www.lonza.com/careers/benefits.
What you will do
- Support the site and customer related regulatory dossier activities for clinical trial and license applications.
- Write CMC regulatory dossiers for Bioconjugates, Microbial, Cell Gene Therapy, Vaccine or Biologicals 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 co-ordinate the regulatory submissions to achieve successful submission outcomes.
What we are looking for
- Degree in Chemistry, Biology, or related Life Sciences discipline with 8+ years of experience in a high regulatory environment.
- 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 ability to influence stakeholders.
- Coll