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.
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· 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
ABAC
