Job Description

The Senior Regulatory Affairs Specialist is responsible for supporting all aspects of regulatory compliance, submission preparation, and product lifecycle management under the direction of the department management. This role also provides cross-functional support to ensure compliance with pharmacovigilance (drug safety) reporting requirements in accordance with FDA and global regulatory standards. Activities may include but are not limited to:

• Compilation/review of original applications (INDs, NDAs, ANDAs), amendments, supplements, annual reports and product labeling in accordance with FDA and ICH guidelines.
• Assessment of regulatory impact of proposed changes to manufacturing facilities and processes. raw material sources, packaging components, and/or controlled documents.

ROLES & RESPONSIBILITIES:

• Product support activities: Compilation and review of FDA Submissions (e.g., NDA/ANDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with change control review/approval and management.
• Additional responsibilities as assigned by management.
• Compile, review, and format regulatory submissions including Annual Reports, original applications (INDs, NDAs, ANDAs), amendments, supplements, and product labeling in accordance with FDA and ICH guidelines.
• Ensure regulatory submissions are accurate, complete, and submitted in electronic Common Technical Document (eCTD) format.
• Support interactions with FDA and other regulatory agencies, including drafting responses to deficiency letters and managing agency correspondence.
• Participate in regulatory intelligence monitoring and maintain awareness of evolving requirements impacting marketed and pipeline products.
• Coordinate with internal and external partners to ensure timely submission of Individual Case Safety Reports (ICSRs), Periodic Adverse Drug Experience Reports (PADERs), and Field Alert Reports (FARs).

QUALIFICATIONS:

• Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing).
• Minimum of two years’ experience plus a Regulatory Affairs Certification or four years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment.

KNOWLEDGE, SKILLS AND ABILITIES:

• Competency with regulations, policies, and procedures relating to company and regulatory guidelines
• Ability to multitask and manage multiple projects with interdisciplinary teams
• Effective communication (verbal and written) with external and internal customers, vendors, and regulators.
• Participation and familiarity with post-approval submissions to FDA, and with ad/promo materials to FDA as well as hands-on experience reviewing and approving labeling and marketing regulatory materials.
• Strong planning and organizational / project / workload management skills.
• Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects.
• Strong ability to work independently as well as in a team environment.
• Ability to drive projects to completion with minimal guidance.
• Solid interpersonal (verbal and written) communication skills at all levels.
• Formal project management skills are a plus.
• Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus. Regulatory publication experience using eCTD software is a plus.
• Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat, including database management and support. SAP experience a plus.
• Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred.
• Experience with metrics management and reporting.
• Proven negotiation skills with internal and external stakeholders.

TRAVEL REQUIREMENTS & WORKING CONDITIONS:

• May require occasional travel as needed
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of office work
• While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or inspect; write; type; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and smell
• The employee may infrequently lift or move up to 30 pounds
• Job requires close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus

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