Coordinator, Regulatory Operations

Primary Duties and Responsibilities:

• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
• Use various internet document transfer sites to download client files and upload files ready to be sent back to our clients.
• Use, manage and maintain submission files on the company shared drive and submissions drive as per company standard.
• Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, Power Point.
• Create eCTD submissions using the eCTD submissions builder, validation software and electronic submissions viewer.
• Create NeeS, and paper submissions as needed.
• Quality checking smaller, basic daily submissions until experience is gained to progress further.
• Trouble shoot issues on a document level independently. Troubleshooting on a submission level with the help of your manager.
• Send eCTD submissions via the ESG and CESG gateway.
• Burn CDs/DVDs, create appropriate labelling.
• Create courier waybills, pack and ship submission materials as needed.
• Enter time into Paymo, or company chosen database, on a daily basis.
• Attend and contribute to weekly department meetings.
• Obtain and maintain professional regulatory and documentary knowledge in order to provide effective consulting advice.
• The Coordinator may be asked to complete additional and other department services as required.

Experience and Educational Requirements:

• B.Sc in Life Sciences or typically 3-5 years of daily working experience in Regulatory Operations.

Minimum Skills, Knowledge and Ability Requirements:

• Excellent written and verbal communication skills.
• Excellent computer skills previous experience with Microsoft Word and Adobe Acrobat is an asset. 
• Some previous experience with Excel and Power Point is an asset.
• Experience with Non-eCTD electronic Submissions (NeeS) and eCTD software an asset.
• Knowledge of industry guidance’s (Regulatory Operations related and some Regulatory Affairs related), would be an asset to have.
• Ability to multitask with the aim of balancing several projects at once.
• Must have a good understanding of client confidentiality and the importance not to cross project information with one another.
• Results oriented with proven time management, organization and prioritizing skills.
• Must have an acute ability for attention to detail.
• Ability to work well individually and as a team.
• Has a positive attitude and works for the greater good of our clients, the team and the company.
• Is responsible for company supplied hardware and software; contacting Innomar IT when needed for assistance.
• Ability to obtain individual and department goals.
• Excellent project management skills – expected to see all projects through to completion. Expected to have the ability to coordinate with other team members in order to complete all projects on time and advise manager if timelines will not be met and/or help is required. Able to keep accurate, up-to-date records as per company/department guidelines.
• Ability to consistently meet extremely tight deadlines.
• Excellent conflict resolution capabilities and ability to spearhead issues (professionally) and successfully solve as they arise.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

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Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Accessibility Policy

AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.