Xylopia Labs Hiring for Regulatory Affairs and Formulation Development Professionals

Xylopia Labs Pvt. Ltd., a leader in pharmaceutical innovation, is currently seeking talented professionals for its Regulatory Affairs and Formulation Development departments in Ahmedabad. If you have a passion for pharmaceutical development and regulatory compliance, this is an excellent opportunity to advance your career. We are looking for candidates with M. Pharm (Pharmaceutics) qualifications and relevant industry experience.

About Xylopia Labs

Xylopia Labs Pvt. Ltd. is dedicated to advancing healthcare through innovative pharmaceutical solutions. Our commitment to excellence and compliance with global regulatory standards positions us as a leader in the pharmaceutical industry. We focus on the US market, ensuring our products meet the highest standards of quality and efficacy.

Job Openings

Formulation Development Professional

Job Title: Formulation Development Professional
Department: Formulation Development (US Market)
Location: Ahmedabad, Gujarat
Qualification: M. Pharm (Pharmaceutics)
Experience Required: 4-6 years

Job Description:

• Develop and optimize pharmaceutical formulations for the US market.
• Conduct pre-formulation and formulation studies.
• Ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams for successful project execution.

Key Responsibilities:

• Conduct research and development of new pharmaceutical formulations.
• Ensure the formulations meet regulatory standards for the US market.
• Optimize processes to improve product quality and efficiency.
• Prepare and review technical documentation for regulatory submissions.

Regulatory Affairs Professional

Job Title: Regulatory Affairs Professional
Department: Regulatory Affairs (US Market)
Location: Ahmedabad, Gujarat
Qualification: M. Pharm (Pharmaceutics)
Experience Required: 4-7 years (Experience in US regulatory submissions is a must)

Job Description:

• Compile and review ANDA (Abbreviated New Drug Application) and deficiency responses.
• Manage the product lifecycle and regulatory submissions.
• Provide regulatory guidance and address challenges.
• Perform eCTD (Electronic Common Technical Document) uploading and submissions through ESG (Electronic Submission Gateway).

Key Responsibilities:

• Compilation and submission of regulatory documents for the US market.
• Management of product lifecycle from development to post-approval.
• Liaise with regulatory authorities and ensure compliance.
• Maintain up-to-date knowledge of regulatory requirements and changes.

How to Apply:

Interested candidates may send their resume to jnshah@xylopialabs.com.