For The Candidates

Reports to: Sr. Director, Regulatory Affairs

Business Unit/Team: Regulatory Affairs

Job Purpose:

Responsible for managing all operational aspects of preparation, coordination, publishing and archiving (paper or electronic) documentation for submission to regulatory agencies. Ensures that submissions comply with applicable regulations and guidance documents, with intense focus on electronic submission requirements.  Works closely with project and commercial teams to track submissions and ensure completeness and timely filing of documents. Plays a key role in defining electronic documentation/data management and submission processes and establishing these processes within the company.

Key Responsibilities:
(in priority order)

• Independently tracks, assembles and publishes (if required) regulatory submissions, including major applications (eCTD, NDA, IND, MAA, etc) and amendments/updates to existing regulatory applications (annual reports, IND amendments, etc)
• Manage the logistical, tracking and timely submission of advertising and promotional pieces to ensure internal approvals and compliance with regulatory requirements
• Support document authors in the use of submission templates
• Draft routine cover letters and prepare FDA forms for submissions
• Resident expert on FDA?s evolving electronic submission requirements (eCTD and SPL); keeps abreast of industry trends in these areas and recommends system and/or process improvements
• Reviews and provides constructive feedback on documents required for regulatory submissions in terms of format and compliance with regulatory requirements for electronic submissions and recommend appropriate course of action when needed
• Maintains highly organized and accessible regulatory logs and electronic archives
• Manage import to archive of regulatory documentation (paper or electronic) from partners and acquisitions
• Drafts SOPs and Work Process Documents for preparation of submissions

Deliverables

(expected results)

Timely, high quality health authority submissions.  Well planned and executed strategy for collecting and assembling documentation for submission. Implementation of successful work processes to streamline submission preparation.  Well organized document and correspondence regulatory files.

Complexity/Decision making

Major submissions are highly complex endeavors and require excellent problem solving skills and analytical thinking.  Additionally, the tracking and timely submission of advertising and promotion materials in a fast-paced environment and across multiple brands requires attention to detail and strong organizational skills.  Interpretation and application of precedents and guidelines is required. Extrapolation of previous experience to new or modified situations is necessary.  Decisions will be needed balancing developmental and business needs.  Ability to work calmly under short deadlines and to cope with last minute changes is needed.

Scope Information

Direct reports:  0

Indirect reports:  0

Total direct and indirect reports:  0

Budget directly responsible for:  0

Job scope: branded product support

Challenges

(Most important problems to resolve to achieve the job?s major purpose)

• Need to balance multiple priorities and projects 
• Need to reduce complex tasks to required individual steps for completion
• Work well under pressure to meet deadlines
• Ability to take initiative and find creative solutions
• Ability to continually monitor regulatory affairs operational landscape and educate others within the workplace on possible impact of changes

Position Requirements

• B/MS preferably in a scientific field or information technology field
• 4+ years experience in pharmaceutical, biotechnology or device/diagnostics industry
• 3+ years of regulatory affairs experience is required
• Experience submitting electronic submission to FDA, in depth knowledge of eCTD, IND, NDA, and post approval submission requirements
• Advanced expertise with relevant submission software - Adobe, Microsoft Office, document management systems (preferably SCORE), XML viewers, SPL, system validation software, submission publishing software.
• Communication and writing skills to interact effectively with all levels of the organization
• Highly organized and detailed orientated, creative thinking ability, team player