Job Description

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Description

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.

Job Description

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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.

Qualifications

Education

• Master Degree (MS/MA) in Science (Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) - Required

Experience

• 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 - Advanced
• High accuracy and attention to detail, while meeting deadlines - Advanced
• Excellent written and verbal communication skills and interpersonal skills - Advanced
• Effective and respectful communication within a team - Advanced
• Ability to interface with professionals domestically and abroad - Advanced
• Independent work ethic, self-starter - Advanced
• Collaborative team player - Advanced
• Problem-solving skills, regulatory strategy understanding, and task prioritization - Advanced

Specialized Knowledge

• Experience with Biologics License Applications (BLAs)
• Knowledge of ICH and FDA regulations
• Experience in regulatory submission and approval processes, dealing with complex CMC issues
• Ability to critically evaluate scientific data
• Leadership experience in regulatory affairs
• Knowledge of Module 3, 4, 5, etc.
• Proficiency in MS Word, Excel, Outlook, eCTD, and Adobe Acrobat
• Good presentation and scientific writing skills

About Us

Amneal is an Equal Opportunity Employer committed to diversity and inclusion in the workplace.

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