Regulatory Affairs Sr. Executive/Executive and Asst. Manager Walk in Hyderabad | Cronus Pharma
- Opportunities at Cronus Pharma for Regulatory Affairs Professionals
- Walk-in Interview for Regulatory Affairs at Cronus Pharma
- Position 1: Sr. Executive/Executive – Regulatory Affairs
- Experience & Qualification:
- Key Responsibilities:
- Required Skills:
- Contact Details:
- Position 2: Asst. Manager – Regulatory Affairs
- Experience & Qualification:
- Key Responsibilities:
- Required Skills:
- Contact Details:
- Interview Location:
Opportunities at Cronus Pharma for Regulatory Affairs Professionals
Cronus Pharma is actively seeking experienced professionals to join our Regulatory Affairs team. This walk-in interview is a fantastic opportunity for candidates with relevant qualifications and experience to become part of a dynamic organization focused on finished dosage formulations for USFDA and EU markets. We have openings for both Sr. Executive/Executive and Asst. Manager positions in Regulatory Affairs.
Walk-in Interview for Regulatory Affairs at Cronus Pharma
Date: October 6th – Sunday
Time: Morning 10 AM to 4 PM
Interview Location: Capital O Hotel Millennium Grand, Miyapur, Telangana
Hotel Address: 1-72, Sriven Mall, Bollaram Rd, Jaya Prakash Narayan Nagar, Miyapur, Telangana 500049
Position 1: Sr. Executive/Executive – Regulatory Affairs
Experience & Qualification:
- Education: M.Pharm / M.Sc. / B.Pharm or science background
- Experience: 5 to 6 years of experience in Regulatory Affairs (finished dosage formulations) for USFDA and EU submissions.
Key Responsibilities:
- Dossier Preparation: Compile dossiers for new/original product registrations (Injectables & Solid Oral Dosage forms).
- Gap Analysis: Perform technical document gap analysis from cross-functional teams (CFT).
- Coordination: Work with R&D, QA, QC, Production for submission requirements.
- Product Labeling: Review and manage product labeling compliance.
- Life Cycle Management: Support in the management of product registration lifecycle.
- R&D Collaboration: Contribute to pre-development activities.
Required Skills:
- Knowledge and experience in US regulatory submissions is a must; EU submissions is a plus.
- Familiarity with FDA, CGMP, ICH, DMF guidelines.
- Hands-on experience in CMC submissions and label management.
- Excellent verbal and written communication skills.
- Ability to work independently and handle multiple tasks.
Contact Details:
- HR Contact: 7337445157 / 7337445197
- Email: hr@cronuspharma.com / planthr@cronuspharma.com
Position 2: Asst. Manager – Regulatory Affairs
Experience & Qualification:
- Education: M.Pharm / M.Sc. / B.Pharm or science background (Regulatory certifications like RAPS preferred).
- Experience: 8 to 10 years of experience in Regulatory Affairs of finished dosage formulations, focusing on USFDA and EU markets.
Key Responsibilities:
- Dossier Authoring: Review technical documents and compile dossiers for injectables in CTD format (US-ANADA).
- Query Response: Prepare responses to CMC queries and coordinate with cross-functional teams (CFT).
- Change Controls: Assess change controls (injectable facility & CMC) and finalize reporting categories.
- Life Cycle Management: Manage post-approval life cycle activities such as CMC supplements and Annual Reports.
- R&D Guidance: Provide guidance to R&D during product development and coordinate with US Agents regarding submission requirements.
- Team Leadership: Mentor and coach the regulatory affairs team, ensuring compliance with current guidelines.
- Software/Hardware Management: Maintain regulatory submission tools and stay updated with the latest technology needs.
Required Skills:
- Strong knowledge of FDA, CGMP, ICH, DMF guidelines.
- Experience in labeling revisions, submissions, and supplemental applications.
- Excellent written and verbal communication skills.
- Proven ability to manage a team and work independently.
- Proficient in Microsoft Office and compliance software.
Contact Details:
- HR Contact: 7337445157 / 7337445197
- Email: hr@cronuspharma.com / planthr@cronuspharma.com
Don’t miss this opportunity! Walk-in interviews will be conducted on October 6th, Sunday. If you meet the qualifications and are ready to take your career to the next level, we encourage you to attend the interview at Capital O Hotel Millennium Grand in Miyapur, Telangana.
Interview Location:
- Hotel Address: Capital O Hotel Millennium Grand, 1-72, Sriven Mall, Bollaram Rd, Jaya Prakash Narayan Nagar, Miyapur, Telangana 500049