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Axxelent Pharma Science Private Limited, a company approved by the US FDA & Health Canada, is actively recruiting experienced and skilled professionals to join their dynamic Regulatory Affairs team. This is a crucial opportunity for experts in Formulation CDMO R&D who possess a strong understanding of global compliance.
We are offering multiple vacancies (12 Nos) across various senior and mid-level positions.
Openings and Candidate Profile
We are seeking professionals for the following designations:
- Executive
- Senior Executive
- Assistant Manager
- Deputy Manager
- Manager
Essential Qualifications:
Candidates must have a degree in:
- B Pharm / M Pharm
- B Tech / M Tech (Pharma / Biotech)
Experience Required:
We are looking for professionals with 2 to 12 years of experience in Regulatory Affairs—specifically for Formulations.
Key Skills and Expertise
Successful candidates will demonstrate expertise in the following areas:
- Global Dossiers: Preparation and submission of dossiers for major international agencies including the US FDA, EMA (Europe), and Health Canada.
- Regulatory Knowledge: A strong understanding of the regulations and guidelines from the US, EU, Canada, UK, and ICH, including eCTD structure and GMP compliance.
- Post-Approval Activities: Experience in managing post-approval activities, which encompass renewals, amendments, and change control management for marketed products.
- Intelligence & Compliance: Proficiency in Regulatory Intelligence & Compliance pertaining to Key Markets & Agencies.
- Technical Acumen: Technical and Scientific Acumen related to different Dosage forms.
- Communication: Excellent written and verbal communication skills for effective interaction with regulatory agencies and internal stakeholders.
Location and Contact Information
- Location: IIT M Research Park, Taramani, Chennai.
How to Apply:
Interested candidates are invited to submit their resumes to the following email addresses:
- vrpradeep@axxelent.com
- corphr@axxelent.com
For quick communication, you may also reach out via WhatsApp:
- WhatsApp: 9789098123
To learn more about Axxelent Pharma Science, please visit our website: www.axxelent.com
