858 Area Code San Diego
SENIOR PUBLICATION SPECIALIST / MANAGER REGULATORY OPERATIONS
The company seeks an outstanding individual for the role of Senior Specialist or Manager Regulatory Operations in the Regulatory Affairs/ Quality Assurance Department (RA/QA). The person will be responsible for electronic submission in eCTD format and as appropriate, paper submissions to regulatory agencies. He/she will provide expert technical guidance within RA/QA and to other functional areas on electronic regulatory submissions and provide document template training to authors. The individual is also familiar with and trained in document management practices and will support our archive system of documents.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These include, but are not limited to:
• Responsible for the coordination, compilation and submission of all submissions to regulatory agencies such as:
• Investigational New Drug Applications (IND)
• New Drug Applications (NDA)
• IND/IMPD/NDA Supplements
• IND/IMPD/NDA Annual Reports
• Periodic Safety Update Reports
• Drug Master Files
• Adverse Event Reports
• Marketing Authorization Requests
• Clinical Trial Applications
• Meeting requests
• Request for Designations
• DDMAC submissions
The individual manages, in close collaboration with the Regulatory Strategy lead, the generation of regulatory submission content and the submission timelines. He/she oversees and executes publication activities, and utilizes document management, authoring, and publishing tools. The individual will use the eCTD and all processes surrounding this capability. The individual will coordinate and supervise the QC of the electronic compilation of the submission. Through management of tracking systems, the individual will be able to inform senior management real time of the status of an ongoing submission. The individual is familiar with submissions to FDA through the electronic gateway.
• Ensures that all aspects of electronic submissions meet regulatory agency and our company’s submission standards and technical requirements. The individual is familiar with the requirements of the life cycle management of electronic submissions.
• Develops work instructions, check lists, and where necessary, SOPs, to document and streamline the work of the Regulatory Operations group.
• Develops and provides template training on a regular and recurring basis to authors of submission
documents.
• Manages and streamlines, in collaboration with team members, the Regulatory Operations document
management system
• • Works with vendors as well as with colleagues here at our co.
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
• Perform validation of eCTD publishing systems
• Support of due diligence activities
• Other duties as assigned.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
• Ideally a BS or BA in a scientific field with 8 years experience in the pharmaceutical or biotech industry
• ICH eCTD experience
• Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents,
• Knowledge of GMP’s, GLP’s and GCP’s is desirable
• Good writing and verbal communication skills.
• Ability to work independently
• Ability to work in team environments
• Ability to think and work strategically
• Good problem solving skills
• Ability to multitask and work within a fast-paced dynamic team environment
• Ability to be the operational lead of a major submission and to coordinate and supervise the work of team members and vendors.
• Project management skills in order to plan and coordinate big submissions
TECHNICAL KNOWLEDGE REQUIRED:
Equipment: PC, scanners, facsimile machine, voice mail and e-mail systems, and common office machines, or ability to be trained. Knowledge of other equipment required:
Software Knowledge: Windows, MS Office (Outlook, Word, Excel). Knowledge of other software required: Adobe, XML and SML authoring tools, ISI Toolbox, Octagon ViewPoint eCTD Software, Pilgrim Software, SAS file formats, Prizm, EDMS, Sharepoint
INTERNAL AND EXTERNAL RELATIONSHIPS:
• Reports to the Head of Regulatory Operations
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 20 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.
TRAVEL:
Travel may be required up to 5% of your time
PERSONAL CHARACTERISTICS:
As the Company is poised to move to its next level, it is imperative that he or she be first and foremost a team player. The successful individual will also possess many critical personal characteristics, including:
Excellent Communication Skills, both written and oral: The successful individual's communication style should be diplomatic and direct, but not confrontational. He or she must be able to articulate clear, tangible objectives for the organization and can deliver an honest assessment of the level of achievement of those goals. He or she must work well in a collaborative team environment.
Accountability: The successful candidate must be able to quickly energize the organization and to focus it throughout its future growth stages. He or she should be a self motivated, results oriented team player who leads by example, holds him or herself accountable for performance, takes absolute ownership, and champions all aspects of the programs.
Indomitable Work and Teamwork Ethic: The successful candidate will reject setbacks and will enthusiastically persevere until ambitious goals are achieved, both personally and from a team perspective. He or she will be resourceful and innovative at tackling multiple challenges.
Entrepreneurship, sense of urgency: The successful candidate will possess a high energy level, which allows him or her to react to situations quickly and decisively, possessing self confidence to be assertive when taking a position, not being afraid to make decisions.
Integrity and Presence: The successful candidate will understand the importance of maintaining a high level of integrity. As such, he or she must project the appropriate professional image of the Company.
