Tayseer Basheer

-Managed regulatory submissions and product registrations for pharmaceutical products, ensuring compliance with global regulations.

-Prepared and submitted regulatory documents, including INDs, NDAs, ANDAs, and variations, in accordance with agency guidelines and timelines.

-Liaised with cross-functional teams, including R&D, Quality Assurance, and Clinical Operations, to gather necessary information for regulatory submissions.

-Reviewed and assessed regulatory impact on product development plans, providing guidance on regulatory strategies to support successful product registration and launch.

-Collaborated with regulatory authorities during inspections and audits, addressing any findings or inquiries in a timely manner.

-Maintained regulatory documentation, including regulatory files, correspondence, and submission records, ensuring accuracy and completeness.

-Participated in cross-functional teams to support labeling and packaging compliance, adverse event reporting, and regulatory compliance initiatives.

• Worked with governance committees to make and evaluate plans.
• Performed and documented quality control checks to maintain compliance with company initiatives.
• Prepared and maintained document inventory for core dossier preparation.
• Represented company in medical /pharmaceutical industry during communications with global regulatory agencies.
• Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
• Consulted with regulatory representatives to manage filings, applications and reports.
• Directed documentation efforts to comply with domestic and international regulations and standards.
• Excellent communication skills, both verbal and written.
• Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.

• Worked with governance committees to make and evaluate plans.
• Performed and documented quality control checks to maintain compliance with company initiatives.
• Prepared and maintained document inventory for core dossier preparation.
• Represented company in [Type] industry during communications with global regulatory agencies.
• Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.
• Consulted with regulatory representatives to manage filings, applications and reports.
• Directed documentation efforts to comply with domestic and international regulations and standards.
• Excellent communication skills, both verbal and written.
• Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.

egulatory Compliance: Ensuring compliance with local, regional, and international regulations governing the development, manufacturing, and marketing of pharmaceutical products. This involves staying up to date with changes in regulations and guidelines and ensuring that all processes and documentation meet the required standards.

Regulatory Strategy Development: Developing and implementing regulatory strategies to support the successful registration and approval of pharmaceutical products. This includes conducting regulatory assessments, creating submission plans, and providing guidance on regulatory requirements to cross-functional teams.

Regulatory Submissions: Preparing, reviewing, and submitting regulatory documents to health authorities, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and variations or amendments to existing applications. Ensuring that submissions are accurate, complete, and comply with regulatory guidelines.

Liaison with Health Authorities: Acting as the primary point of contact for interactions with health authorities, such as the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory agencies. This involves participating in meetings, responding to queries, and facilitating communication between the company and regulatory authorities.

Regulatory Compliance Audits: Conducting internal audits to assess compliance with regulatory requirements and identifying areas for improvement. Developing and implementing corrective and preventive actions to address any compliance gaps.

Regulatory Training and Education: Providing training and education on regulatory requirements and processes to internal stakeholders, including employees involved in product development, manufacturing, and quality assurance.

Regulatory Documentation Management: Maintaining accurate and up-to-date regulatory documentation, including regulatory submissions, correspondence with health authorities, and regulatory databases.