Purpose and Scope

Under supervision, assist in all functions pertaining to international regulatory submissions including preparation of documents for electronic or paper filing for new prescription drug products.

Essential Duties & Responsibilities

• Create, review and/or maintain global drug product applications, which includes but it not limited to creating and/or review eCTD documents for international regulatory submissions for prescription drug products (new applications, amendment, variations, renewals, etc.).
• Coordinate with personnel from other departments to obtain data/documentation for global regulatory submissions.
• Review submission packages (for global marketing partners) for accuracy and completeness.
• Track and maintain timelines for all assigned projects, including documentation required to support global registrations and licensing activities.
• Ensure responses to internal/external queries are provided on time.
• Respond and track deficiencies received from global marketing partners, coordinating with cross-functional teams to gather data to support a response.
• Assist and serve as the regulatory representative on relevant project teams, if needed. Offer regulatory opinions with consultation from regulatory supervisor.
• Assess drug product change controls and their impact on projects. Work with global marketing partners to obtain their impact assessment.
• Review draft investigational and commercial labeling artwork, if required.
• Review global regulatory and government regulations/guidelines for regulatory impact to procedures, when needed.
• Assist regulatory management and other regulatory associates as requested.
• Perform regulatory research tasks as requested.
• Maintain electronic document management system as required.
• Conform to regulatory department standards.
• Review controlled documents.

• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Proficient knowledge of word processing, specifically MS Office, and Adobe Reader/Writer.

• Maintain up-to-date knowledge of current guidance and regulations.

• Excellent writing and organizational skills.
• Ability to coordinate information from various internal and external disciplines.
• Ability to understand regulatory and technical concepts and requirements.
• Ability to perform multiple tasks on several projects.
• Ability to prepare written summaries of technical data suitable for inclusion in regulatory submissions.
• Ability to understand, and comply with domestic and international regulatory requirements.
• Ability to follow specific directions and to request instructions for complex tasks.
• Ability to learn and work independently.

Core Values

• The Regulatory Associate II –Alliance Management is expected to operate within the framework of Tolmar’s Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• Bachelor’s degree in related field.
• Two or more years’ experience in the pharmaceutical industry with knowledge and experience in preparing and submitting regulatory dossiers/applications to regulatory agencies.

Working Conditions

• Remote or Tolmar site (normal office environment)
• Minimal Travel Required

Compensation and Benefits

Annual Pay Range: $70,000-80,000
Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Experience

• 2 year(s): • Two or more years’ experience in the pharmaceutical industry with knowledge and experience in preparing and submitting regulatory dossiers/applications to regulatory agencies.

Education

• Bachelors or better in Science or related field

Licenses & Certifications

• RAC

Behaviors

• Team Player: Works well as a member of a group
• Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)