Subject matter expert in the area of Biologics. Promotes and develops initiatives to continually improve working relationships within and across departments in relation to department and company goals and objectives.
Essential Functions:
Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and Small Molecules.Ensure alignment with regulatory trends, innovation, and compliance while balancing business benefits and risks.
Lead and Manage Global Submission Activities: Oversee submission planning, authoring, reviewing, and coordination for regulatory filings (e.g., BLA, MAA). Identify required documentation and ensure timely, high-quality submissions meeting global requirements.
Health Authority Interactions and Negotiations: Initiate and lead Health Authority interactions, including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory issues.
Provide Regulatory Guidance and Compliance Oversight: Offer strategic regulatory advice to cross-functional teams and ensure compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance documents.
Support Development, Submission, and Post-Approval Activities: Collaborate on development, submission, and post-approval activities from a regulatory perspective. Maintain partnerships with internal and external stakeholders to ensure smooth regulatory processes.
Additional Responsibilities:
Maintain awareness of all regulatory activities regarding new and approved drug products. Stay current with state-of-the-art standards on the regulatory process.
11 years or more in Regulatory Affairs in biologic industry experience
Skills:
Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. - Advanced
Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. - Advanced
Excellent written and verbal communication skills and interpersonal skills. - Advanced
Ability to communicate effectively and collaboratively as part of a team in a respectful manner. - Advanced
Ability to interface with professionals domestically and abroad. - Advanced
Ability to work independently, self-starter. - Advanced
Ability to work collaboratively in a team structure. - Advanced
He/she will demonstrate effective problem solving, strong understanding of regulatory strategies, excellent interpersonal skills and the ability to prioritize multiple tasks. - Advanced
Specialized Knowledge:
Prior experience working with Biologics License Applications (BLAs).
Knowledge of ICH and FDA regulations.
Substantial knowledge/experience in regulatory submission and approval processes and ability to deal with complex CMC regulatory issues and requirements.
Proven ability to critically evaluate data from a broad range of scientific disciplines.
Leadership experience within regulatory affairs function.
Broad knowledge on Module 3, Module 4, Module 5 etc.
Broad knowledge of ICH and FDA regulations and regulatory guidelines.
Proficient in MS Word, Excel, Outlook, eCTD software and Adobe Acrobat.
Good skills in presentation and scientific/technical writing.
About Us
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Seniority level
Director
Employment type
Full-time
Job function
Legal
Industries
Pharmaceutical Manufacturing
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