Regulatory Affairs Operations Specialist

2 weeks ago

Raleigh, United States Merz Therapeutics Full time
Based in the Raleigh, NC Corporate office - Hybrid

Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we're embarking on a transformative journey, blending time-honored traditions with exciting new products.

As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.

If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU #IAmMerz

Are you ready to galvanize a team around a culture of care, putting patients first to spark change?

The Regulatory Operations Specialist will be responsible forthe planning, compilation, and publishing of both routine and complex submissions as well as document archiving of Merz products. This role will ensure quality assurance of submission documentation and published output for technical completeness and accuracy. The Regulatory Operations Specialist will maintain familiarity with current regulatory submission standards and industry best practices. They will collaborate with Regulatory Affairs staff and contributing functional areas to assure adequate prioritization and scheduling of regulatory submissions. This role will help with other projects and activities as assigned by management to support the Regulatory Operations function.

Major duties

Description

Publishing/Dossier Management

Compile, format, and publish regulatory submissions in accordance with electronic Common Technical Document (eCTD) requirements.

Publishing/Dossier Management

Ensure accuracy and completeness of regulatory submissions, prior to submission to health authorities.

Publishing/Dossier Management

Collaborate with cross-functional teams to gather necessary information and documents for regulatory submissions and provide guidance and support on publishing requirements and processes.

Publishing/Dossier Management

Maintain regulatory submission timelines and ensure timely submission of documents to health authorities.

Publishing/Dossier Management

Perform Regulatory Information Management tasks including file transfer, storage, tracking and archival of Regulatory submission documentation, including agency correspondence in a time-sensitive manner

Publishing/Dossier Management

Assist in the development and implementation of processes to streamline regulatory publishing activities and improve efficiency.

General Regulatory Duties

Stay current with regulatory guidelines and industry best practices related to electronic submissions and regulatory publishing.

General Regulatory Duties

Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.

Regulatory Systems

Support in-house training to ensure optimal use of templates, processes, and tools critical for submission documents and information management.

Education

Bachelor's degree is Preferred

Degree in Information Management/Information Technology/Biological Sciences is Preferred

Professional experience

  • Minimum of 3 years pharmaceutical industry experience; preferably within the Regulatory Affairs/Operations function with knowledge of health agency requirements is Required


Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.

Recruitment Note:Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com

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)

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