Purpose and Scope

Under supervision, assist in all functions pertaining to international regulatory submissions, including coordination and preparation of documents for new drug Marketing Authorizations and/or lifecycle management changes. This person will interact and collaborate with internal Tolmar teams and Global Marketing Partners to support Rest of World (RoW) and Canadian submissions.

Essential Duties & Responsibilities

• Compile and track the status of documentation required to support global renewals, including the request of Certificates of Pharmaceutical Products (CPPs), legalization and authentication of documents.
• Respond and track RoW health authority deficiencies received from global marketing partners by coordinating with cross-functional teams and reviewing the adequacy of the responses in conjunction with the supervisor.
• Prepare and coordinate eCTD documentation for new marketing authorizations and lifecycle management submissions for RoW and Canada.
• Assist and serve as the regulatory representative on relevant project teams. Offer regulatory opinions with consultation from Regulatory Affairs Supervisor.
• Coordinate with personnel from other departments to obtain data/documentation for RoW drug product-related submissions, including the support of Tolmar owned applications in Canada.
• Review and provide regulatory assessments for chemistry, manufacturing and control related changes for drug products; share change controls notices with marketing partners, obtaining and tracking feedback.
• Review and approve GMP related documents.
• Prepare, review and approve labeling artwork for RoW and Canadian submissions, as needed.
• Read, review and interpret global regulatory guidelines and government regulations to support RoW and Canadian drug product submissions.
• Assist Regulatory Management and other Regulatory Associates, as requested.
• Maintain electronic document management system, as required, for responsible products.
• Conform to regulatory department standards.
• Perform regulatory research tasks as requested and other duties as assigned.

Knowledge, Skills & Abilities

• Proficient knowledge of word processing, specifically MS Office Suite, and Adobe Reader/Writer.
• Knowledge of Database Management software.
• 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.

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’s 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 a 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

• Working conditions are consistent with a normal office environment and/or remotely from home office.
• 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.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

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)