Regulatory Affairs Specialist
Lonza · Hyderabad · onsite · Posted 28d ago
Undisclosed6–11 yrsfulltimeSourced from
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About this role
Job Summary
What you will get
What you will do
What we are looking for
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Regulatory Affairs 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 Specialist in Regulatory Affairs (CMC), you will be responsible for site and customer CMC writing actvities for clinical trial application and product lifecycle support.
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 benefits can be found here.
What you will do
- Support the site and customer related regulatory dossier activities for clinical trial applications.
- Write CMC regulatory dossiers for Drug Substance filing (small and Large API Molecules) using source documents, ensuring accuracy, completeness, and compliance.
- Support product lifecycle management activities
- 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 6+ years of experience in highly regulated 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.
- Collaborative, proactive, and solution-oriented mindset with strong accountability and ownership.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Product Life Cycle ManagementAgileDocument ManagementHashiCorp VaultDossierRegulatory AffairsEctdregulatory submissionsbiologyChemistryVeeva vaultProject ManagementCommunication SkillscomplianceLife Sciences
About Lonza
Lonza
Pharma
174
employees
1897
129 years old
Basel
Switzerland
About
A prominent provider of healthcare solutions, focusing on innovative therapies for disease prevention and specialized ingredients for various industries.
Industries
PharmaChemicals / Agri InputsManufacturing
Employee ratings
36 reviews
3.5/ 5
Culture
3.4
Career growth
2.5
Work-life
4.1
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