New London, CT - Regulatory Submissions Support

Job Description:

• To execute against required dossier development build and publishing activities within Submissions & Product Licensing Support (S&PLS) ensuring that the company delivers on all regulatory submission milestones and maintains compliance with applicable regulatory obligations
• This role reports to the Submissions Team Leader and sits within a team working to tight, business-critical deadlines within a highly regulated environment
• Primary accountability is for the designated region/areas of responsibility, with additional accountability to support other publishing locations through utilization of global tools
• Delivering project specific company paper and electronic submissions
• Co-ordination and execution of publishing solutions that meet unique requirements of each submission, and management of product delivery to regulatory agencies
• Maintain a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier format and publishing requirements as required
• Work with the Submission Team Leaders to effectively manage project specific resources utilizing flexible resourcing, and global load sharing as normal business practice
• Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved

REQUIREMENTS:

• Advanced Microsoft Office Suite skills
• MS Excel   Required 1-3 Years Intermediate
• MS Outlook   Required 1-3 Years Intermediate
• MS Word   Required 1-3 Years Intermediate
• Pharmaceutical   Desired 1-3 Years
• Regulatory Documentation   Required 1-3 Years
• Proven experience managing or delivering through others in a matrix environment
• Demonstrated coordination of activities in a highly regulated environment
• Formal training in technical tools
• Strong knowledge of drug development process
• Demonstration of experience working in a customer service environment
• Relevant experience in electronic submissions build within the Pharmaceutical Industry
• Ability to follow regulatory guidance and practices pertaining to technological aspects of submission management
• Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards
• Bachelor Degree Level (desirable)
• Proven technical aptitude and fluency with publishing tools
• Familiarity with pharmaceutical organizational structures, systems, and culture is preferred
• Proficient in the use of Publishing and Document Management tools
• Experience with building a full paper and electronic submission

Functional/Technical Skills

• Has the functional and technical knowledge and skills to do the job at a high level of accomplishment

Acts Decisively

• Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure
• Able to make a quick decision

Seizes Accountability

• Will stand up and be counted; doesn’t shirk personal responsibility
• Can be counted on when times are tough
• Willing to be the only champion for an idea or position
• Is comfortable working alone on a tough assignment

Change Agile

• Can effectively cope with change
• Can shift gears comfortably
• Can decide and act without having the total picture
• Isn’t upset when things are up in the air
• Doesn’t have to finish things before moving on
• Can comfortably handle risk and uncertainty

Peer Relationships

• Can quickly find common ground and solve problems for the good of all
• Can represent his/her own interests and yet be fair to other groups
• Can solve problems with peers with a minimum of noise
• Is seen as a team player and is cooperative
• Easily gains trust and support of peers
• Encourages collaboration
• Can be candid with peers

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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