Full-Time Manager Regulatory Submissions
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Jo Manager – Regulatory Submissions
The Assistant Manager – Regulatory Submissions will be responsible for assisting the Manager – Regulatory Submissions and/or Senior Manager – Regulatory Submissions to build and maintain the electronic regulatory submissions to Health Authorities. In this position, the Assistant Manager will assist in the formatting, reviewing, checking, filing and archiving of regulatory submission documents for investigational and marketed products.
*Essential Duties and Responsibilities Include the Following: Other duties may be assigned.
Review and prepare paper and/or electronic submission documents for the Health Authorities.
Learn and manage the eCTD publishing and electronic document management software.
Assist with creating and updating templates and other documents for regulatory submissions.
Responsible for critical reviewing regulatory submissions (both paper and electronic).
Demonstrated ability to work within a cross functional team and a matrix environment.
Tracking and ordering of submission and equipment supplies.
Learn current relevant regulations for the preparation and maintenance of regulatory dossiers to Health Authorities.
Education and/or Experience
Bachelor’s degree in Chemistry or Biology or Pharmaceutical Science or related field required
Minimum of 1-3 years experience in the pharmaceutical industry; some experience in regulatory affairs is preferred.
Strong skills in planning, organizing, decision-making and problem-solving
Able to work well with employees across the organization and has strong interpersonal skills
Excellent writing communication skills;
Knowledge of FDA/ICH regulatory guidelines is preferred
Good working knowledge of Microsoft Office programs (Word, PowerPoint, and Excel).
Experience with document management/publishing software for electronic submissions is an asset.
Must be able to physically lift approximately 10 pounds and stand for at least 30 minutes at one time
Able to work in a high paced demanding environment to meet the regulatory needs for the company
Other Skills and Abilities:
Excellent time management skills and an ability to work on multiple projects at any given time
No specific work demands
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions