Develop and implement global regulatory strategies for cell and gene therapy products to support successful product
development, registration, and commercialization in the global market.
Prepare, review, and submit regulatory documents, including Investigational New Drug (IND) applications, Biologics
...
License Applications (BLAs), and other regulatory submissions to the regulatory agencies, ensuring accuracy,
completeness, and adherence to regulatory requirements.
Stay abreast of relevant regulations, guidelines, and industry trends pertaining to cell and gene therapy products.
Interpret regulatory requirements and provide guidance to internal teams to ensure compliance throughout the
product lifecycle.
Collaborate closely with internal stakeholders, including Research and Development, Clinical Operations, Quality
Assurance, and Manufacturing, to integrate regulatory considerations into product development plans and timelines.
Serve as the primary point of contact for regulatory agencies, including the FDA, representing the company in
interactions such as pre-submission meetings, regulatory submissions, and responses to inquiries.
Identify potential regulatory risks and develop mitigation strategies to address them effectively. Proactively assess
regulatory implications of changes to product development plans and provide recommendations to minimize
regulatory impact.
Monitor regulatory developments, competitive landscape, and industry best practices related to cell and gene therapy
products. Provide insights and recommendations to inform strategic decision-making and maintain a competitive edge. Minimum of 5+ years of experience in regulatory affairs within the biopharmaceutical or biotechnology industry, with
specific expertise in cell and gene therapy products.
Proven track record of successful regulatory submissions and approvals for biologics products in the US market,
including INDs and BLAs.
In-depth knowledge of FDA and EMA regulations, guidelines, and procedures related to cell and gene therapy products.
Strong understanding of the drug development process, including clinical trial design, Good Clinical Practice (GCP), and
Good Manufacturing Practice (GMP) requirements.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams
and regulatory agencies.
Strategic mindset with the ability to think critically, anticipate regulatory challenges, and develop innovative solutions.
show more
Develop and implement global regulatory strategies for cell and gene therapy products to support successful product
development, registration, and commercialization in the global market.
Prepare, review, and submit regulatory documents, including Investigational New Drug (IND) applications, Biologics
License Applications (BLAs), and other regulatory submissions to the regulatory agencies, ensuring accuracy,
completeness, and adherence to regulatory requirements.
Stay abreast of relevant regulations, guidelines, and industry trends pertaining to cell and gene therapy products.
Interpret regulatory requirements and provide guidance to internal teams to ensure compliance throughout the
product lifecycle.
Collaborate closely with internal stakeholders, including Research and Development, Clinical Operations, Quality
Assurance, and Manufacturing, to integrate regulatory considerations into product development plans and timelines.
Serve as the primary point of contact for regulatory agencies, including the FDA, representing the company in
interactions such as pre-submission meetings, regulatory submissions, and responses to inquiries.
...
Identify potential regulatory risks and develop mitigation strategies to address them effectively. Proactively assess
regulatory implications of changes to product development plans and provide recommendations to minimize
regulatory impact.
Monitor regulatory developments, competitive landscape, and industry best practices related to cell and gene therapy
products. Provide insights and recommendations to inform strategic decision-making and maintain a competitive edge. Minimum of 5+ years of experience in regulatory affairs within the biopharmaceutical or biotechnology industry, with
specific expertise in cell and gene therapy products.
Proven track record of successful regulatory submissions and approvals for biologics products in the US market,
including INDs and BLAs.
In-depth knowledge of FDA and EMA regulations, guidelines, and procedures related to cell and gene therapy products.
Strong understanding of the drug development process, including clinical trial design, Good Clinical Practice (GCP), and
Good Manufacturing Practice (GMP) requirements.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams
and regulatory agencies.
Strategic mindset with the ability to think critically, anticipate regulatory challenges, and develop innovative solutions.
show more
