Zeiss Pharmaceutical Pvt. Ltd looking for DRA Executive/AM

Pharma Job Alert; Panchkula; On-site; INR 6,00,000 - 12,00,000; Full time

Job summary

An established industry player in the pharmaceutical sector is seeking a Regulatory Affairs Executive/AM to ensure compliance with evolving regulations. This role involves preparing regulatory submissions, providing expertise to cross-functional teams, and managing communications with regulatory agencies. The ideal candidate will have 5-10 years of experience in regulatory affairs, a strong educational background in life sciences or pharmacy, and the ability to navigate complex regulatory environments. Join a dynamic team dedicated to maintaining high standards of regulatory compliance and contribute to the success of innovative pharmaceutical products.

Qualifications

• 5-10 years of experience in regulatory affairs with a focus on product registration.
• Bachelor’s/Master's degree in life sciences or pharmacy is required.

Responsibilities

• Ensure compliance with regulatory guidelines and laws in relevant markets.
• Prepare and submit regulatory submissions to authorities.

Skills

Regulatory Compliance

Documentation and Submissions

Internal Consultation

Agency Interactions

Strategic Planning

Education

Bachelor’s degree in life sciences or pharmacy

Master's degree in regulatory affairs or related field

Job description

We at Zeiss Pharmaceutical Pvt. Ltd, Panchkula are looking for a DRA Executive/AM with the following specifications:

Key Responsibilities of a Regulatory Affairs Executive:

1. Regulatory Compliance:
   Stay updated on current and evolving regulatory guidelines and laws in relevant markets.
   Interpret regulations and assess their impact on product development and commercialization.
   Ensure all company products, labeling, and promotional materials comply with regulatory requirements.
2. Documentation and Submissions:
   Prepare and submit comprehensive regulatory submissions to relevant authorities, including new drug applications, license variations, and renewals.
   Gather and analyze scientific data to support regulatory submissions.
   Manage regulatory documentation, including filing systems and tracking databases.
3. Internal Consultation and Advice:
   Provide regulatory expertise to cross-functional teams, including research and development, manufacturing, and marketing.
   Advise on product development strategies to ensure compliance with regulatory requirements.
   Review product labeling and promotional materials for regulatory compliance.
4. Agency Interactions:
   Respond to inquiries from regulatory agencies and manage communication with authorities.
   Prepare for and participate in regulatory inspections.
   Address any regulatory concerns or non-compliance issues raised by agencies.
5. Strategic Planning:
   Identify potential regulatory risks and develop mitigation strategies.
   Contribute to the development of regulatory compliance policies and procedures.
   Monitor industry trends and anticipate potential regulatory changes impacting the company.

Education and Experience:

1. Bachelor’s/Master's degree in life sciences or pharmacy.
2. Advanced degree (Master’s or PhD) in regulatory affairs or related field may be preferred.
3. 5-10 years relevant experience in regulatory affairs within the industry, ideally with a focus on product registration and compliance.

Interested candidates can share their updated CV with Current CTC, Expected CTC, Total Experience, Notice Period & Current Location at [e-mail] and WhatsApp [phone].