Regulatory Affairs Jobs In Mumbai For Freshers at Pelltech Healthcare

About Company

PELLTECH HEALTHCARE PRIVATE LIMITED is a WHO-GMP certified pharmaceutical company headquartered in Mumbai, Maharashtra, India. Pelltech specializes in manufacturing and developing excellent high quality generic oral solid dosage forms and mainly focuses on developing modified-release pellets and finished formulations in tablets and capsules. For more details about the company, please visit the official website of Pelltech Healthcare Pvt. Ltd.

• DEPARTMENT – Regulatory Affairs
• DESIGNATION – Regulatory Affairs Executive
• DIVISION – Agreed Regulatory Strategy and Standards
• EXPERIENCE – Freshers & Experienced

What are the job responsibilities of the Job Role?

1. Understand and maintain compliance with regulatory and promotional standards.
2. Ensure the execution of necessary actions for the registration of new products or renewal in a timely fashion.
3. Interact with the manager and departmental teams to discuss critical topics and resolve the issues in a timely and proactive manner.
4. Handle the planning, preparation, and execution of regulatory submissions and ensure the preparation of regulatory documents as per the project timelines.
5. Analyze and evaluate gap analyses on dossiers to track and resolve any discrepancies in regulatory compliance.
6.  Ensure timely registration of new products and registration renewal to avoid violation of regulatory guidelines.
7. Utilize the database system to optimize the submission and approval status. 
8. Assist in creating and designing SOPs related to regulatory operations.

What is the required educational qualification?

Interested candidates can apply for the job role of Regulatory Affairs Executive to begin their professional journey in the Regulatory Affairs field, Please read the article carefully to get more details about the eligibility criteria for the position.

• Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)
• Specialized degree in Pharmaceutical Technologies and Formulation & Development
• Freshers are welcome to apply for the job.
• Minimum 01 year of experience in regulatory affairs in OSD, QC, and Research and Development (R&D).
• Good knowledge of pharmaceutical regulatory guidelines like NDA, MHRA, and FDA guidelines.

What skills and Expertise are required to get the position?

Candidates willing to work in the Regulatory Affairs department must have analytical and data interpretation skills, and the ability to effectively utilize Regulatory Data Management tools like Veeva RIM, eCTD software, and TrackWise. Candidates must stay updated with the latest trends and regulatory changes.

What salary does the company offer for the job role of Regulatory Affairs Executive?

Pelltech Healthcare has offered the job to the eligible candidates for the position of Regulatory Affairs Executive. The company has not disclosed the salary figures, but as per the industry standards, job profile, and experience, the candidates can expect a salary of up to INR 40,000/- per month. The exact salary figures will be disclosed after the selection or will be discussed during an interview.

Disclaimer: The salary figure mentioned is estimated from different websites like Glassdoor, AmbitionBox, etc.

What is the job location?

• Manufacturing Plant Address: Plot No. 20B, Tansa Farm Estate, Village Met, Gonsai, Bhiwandi-Wada Road, Wada, Palghar – 421312, Maharashtra, India.
• Corporate Office Address: 202, Sonmur Apartments, Daruwala Compound, S.V. Road, Malad (W), Mumbai – 400064, Maharashtra, India.

How to Apply for the Pelltech Healthcare Regulatory Affairs Jobs?

Applicants can read all the details by going through the complete job information and can submit their application online using the direct application link mentioned below. 

Direct Application Link: Click Here