Manager / Assistant Manager- Regulatory Affiars
2 months ago
The Regulatory Affairs Specialist will be responsible for preparing, managing, and coordinating regulatory submissions for USFDA (United States Food and Drug Administration) and MHRA (Medicines and Healthcare products Regulatory Agency) approvals for products manufactured at our plant. This role requires comprehensive knowledge of regulatory requirements, excellent organizational skills, and the ability to work collaboratively across departments to ensure compliance with all applicable regulations. This role is critical for maintaining product quality and safety, ensuring that all products meet regulatory standards and customer expectations.
Ensure the plant's compliance with USFDA and MHRA regulations, guidelines, and standards.
Prepare, review, and submit regulatory documents for USFDA and MHRA approval, New Drug
Applications (NDA) including Investigational New Drug (IND) applications, and Marketing
Authorization Applications (MAA) including all necessary documentation such as clinical data, manufacturing information, and labelling.
Ensure all submissions are accurate, complete, and in compliance with regulatory requirements.
Manage the timelines and tracking of regulatory submissions and approvals.
Develop and implement regulatory strategies to ensure timely ANDA submissions and approvals.
Develop, implement, and maintain quality systems and SOPs (Standard Operating Procedures) including validation protocols, batch records, and deviation reports that comply with regulatory requirements.
Stay up-to-date with regulatory changes and updates from USFDA and MHRA.
Ensure the plant’s operations and products comply with all applicable regulatory requirements.
Lead and manage internal and external audits, including USFDA and MHRA inspections. Address and close audit findings by responding to FDA queries and deficiency letters promptly.
.Ensure proper documentation of regulatory strategies, decisions, and interactions with regulatory agencies.
Ensure post-approval compliance with FDA regulations, including handling changes and updates to approved ANDAs.
Qualifications:
Education: Bachelor's degree in Pharmacy , Master of Pharmacy
Experience: Minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Preferably hands on experience of getting the ANDA approval. Experience in ophthalmology product manufacturing is highly desirable.
Regulatory Knowledge: In-depth knowledge of USFDA and MHRA regulations and guidelines. Experience with other international regulatory agencies is a plus.
Skills:
Strong leadership and team management skills.
Excellent communication and interpersonal skills.
Detail-oriented with strong organizational and analytical skills.
Proficiency in quality management systems and software.
Ability to work under pressure and manage multiple tasks simultaneously.
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