Zeiss Pharmaceutical Pvt. Ltd looking for DRA Executive/AM

We at Zeiss Pharmaceutical Pvt. Ltd, Panchkula looking for DRA Executive/AM with below specifications –

Key responsibilities of a Regulatory Affairs Executive:
·        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.
·
·        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.
·        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.
·        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.
·        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:
·        Bachelor’s/Master degree in life sciences, pharmacy.
·        Advanced degree (Master’s or PhD) in regulatory affairs or related field may be preferred
·        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 Exp., Notice Period & Current Location at hr.ho@zpharma.co.in & What Sapp +91 9805479799