Medix
Associate Director of Regulatory Affairs, Biologics - 243376
Medix, Neshanic Station, New Jersey, United States, 08853
Essential Functions
Develop and Execute Regulatory Strategies:
Formulate and lead global CMC (Chemistry, Manufacturing, and Controls) and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules. Ensure these strategies align with global regulatory trends, promote innovation, and balance compliance with business objectives and risks. Manage Global Submissions:
Oversee the entire submission process, including planning, authoring, reviewing, and coordinating regulatory filings. This includes identifying all necessary documentation and ensuring timely, high-quality submissions that meet international requirements. Lead Health Authority Interactions:
Initiate and lead discussions with Health Authorities, preparing briefing books, organizing rehearsals, and developing risk mitigation plans. You will also represent the Global Regulatory team on cross-functional teams to resolve regulatory issues. Provide Regulatory Guidance:
Offer strategic regulatory advice to various teams and ensure adherence to all relevant regulations, including those from the FDA, EMA, and Health Canada. Assess the regulatory impact of changes in CMC procedures and oversee the creation of internal regulatory guidance documents. Support Regulatory Activities:
Collaborate on development, submission, and post-approval activities from a regulatory perspective. Maintain strong partnerships with internal and external stakeholders to ensure a smooth regulatory process. Additional Responsibilities Stay current with all regulatory activities related to new and approved drug products and remain up-to-date on regulatory process standards. Qualifications Education:
A Master's degree (MS/MA) in a science field such as Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, or Biology is required. Experience:
At least 11 years of experience in Regulatory Affairs within the biologics industry. Skills Advanced skills
in time management, organization, and multi-tasking in a fast-paced environment. The ability to maintain a high level of
accuracy and attention to detail
while meeting project deadlines. Excellent
written and verbal communication
and interpersonal skills. The ability to communicate effectively and respectfully with team members. The ability to interface with domestic and international professionals. The ability to work independently as a self-starter and collaboratively within a team. Demonstrated proficiency in
problem-solving , a strong understanding of regulatory strategies, and the ability to prioritize multiple tasks. Specialized Knowledge Prior experience working with
Biologics License Applications (BLAs) Comprehensive knowledge of
ICH and FDA regulations Substantial experience with regulatory submission and approval processes, and the ability to handle complex CMC regulatory issues. Proven ability to critically evaluate data from a wide range of scientific disciplines. Leadership experience
within a regulatory affairs function. Broad knowledge of regulatory submission modules (e.g., Module 3, Module 4, Module 5). Proficiency with Microsoft Office Suite (Word, Excel, Outlook), eCTD software, and Adobe Acrobat. Strong presentation and scientific/technical writing skills.
Formulate and lead global CMC (Chemistry, Manufacturing, and Controls) and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules. Ensure these strategies align with global regulatory trends, promote innovation, and balance compliance with business objectives and risks. Manage Global Submissions:
Oversee the entire submission process, including planning, authoring, reviewing, and coordinating regulatory filings. This includes identifying all necessary documentation and ensuring timely, high-quality submissions that meet international requirements. Lead Health Authority Interactions:
Initiate and lead discussions with Health Authorities, preparing briefing books, organizing rehearsals, and developing risk mitigation plans. You will also represent the Global Regulatory team on cross-functional teams to resolve regulatory issues. Provide Regulatory Guidance:
Offer strategic regulatory advice to various teams and ensure adherence to all relevant regulations, including those from the FDA, EMA, and Health Canada. Assess the regulatory impact of changes in CMC procedures and oversee the creation of internal regulatory guidance documents. Support Regulatory Activities:
Collaborate on development, submission, and post-approval activities from a regulatory perspective. Maintain strong partnerships with internal and external stakeholders to ensure a smooth regulatory process. Additional Responsibilities Stay current with all regulatory activities related to new and approved drug products and remain up-to-date on regulatory process standards. Qualifications Education:
A Master's degree (MS/MA) in a science field such as Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, or Biology is required. Experience:
At least 11 years of experience in Regulatory Affairs within the biologics industry. Skills Advanced skills
in time management, organization, and multi-tasking in a fast-paced environment. The ability to maintain a high level of
accuracy and attention to detail
while meeting project deadlines. Excellent
written and verbal communication
and interpersonal skills. The ability to communicate effectively and respectfully with team members. The ability to interface with domestic and international professionals. The ability to work independently as a self-starter and collaboratively within a team. Demonstrated proficiency in
problem-solving , a strong understanding of regulatory strategies, and the ability to prioritize multiple tasks. Specialized Knowledge Prior experience working with
Biologics License Applications (BLAs) Comprehensive knowledge of
ICH and FDA regulations Substantial experience with regulatory submission and approval processes, and the ability to handle complex CMC regulatory issues. Proven ability to critically evaluate data from a wide range of scientific disciplines. Leadership experience
within a regulatory affairs function. Broad knowledge of regulatory submission modules (e.g., Module 3, Module 4, Module 5). Proficiency with Microsoft Office Suite (Word, Excel, Outlook), eCTD software, and Adobe Acrobat. Strong presentation and scientific/technical writing skills.