Regulatory Affairs Specialist

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 Affairs Specialist coordinates the regulatory activities for life cycle management of marketed pharmaceutical products.

This includes assisting with regulatory timelines as well as coordination of submissions to FDA and Health Canada dossiers under the direction of a line manager.

Responsibilities include coordination and compilation of maintenance submissions for lifecycle management, including CMC, for existing pharmaceutical products.

Additionally, the role will assist in organizing submission of Advertising and Promotional pieces to FDA. These obligations will also require interactions with the Regulatory Operations team to plan, prepare, and complete accurate and timely submissions to Heath Authorities.

Position will primarily support US and Canada drug regulatory submissions including INDs, NDAs, BLAs, NDSs requiring filing of CMC supplements, annual and period safety reports, protocol amendments, and potentially OPDPs.

Major duties

Description

Regulatory Submissions

• Interact with project team members to ensure high quality and timely regulatory submissions for lifecycle management tasks, including annual reports, periodic safety reports, CMC, and labeling.
• Preparation and coordination of life cycle maintenance submissions in accordance with the current regulations and guidance’s.

Ensure submissions support company objectives and strategy.

Communication with Regulatory Authorities

• Support the regulatory interactions with regulatory health agencies, contract manufacturers, affiliates and distributors as necessary.
• Document and archive these discussions and communicate discussions with internal stakeholders as necessary.

Regulatory Intelligence

• Maintain current knowledge of regulations and guidelines related to company’s activities and products.
• Communicate to internal stakeholders the interpretation and implications of regulations and guidance as necessary.

Labeling

Assist in the submission of labeling supplements.

Other duties as assigned

• Provide support to other regulatory staff as needed and perform duties and assignments as required. Communicate and raise questions / issues to the attention of regulatory management.
• Additional duties as needed to support the business and overall company objectives.

Education

Bachelor’s degree is Required

Degree in Scientific or Health Discipline is Preferred

Professional experience

Minimum 1-2 years relevant regulatory experience required

Knowledge, skills and abilities (incl. languages)

• Proficient in all MS Office applications required
• Demonstrated organizational skills, strong verbal and written communication skills, and attention to detail including strong proofreading skills required

Knowledge of methods

Ability to handle multiple tasks and to prioritize and schedule work to meet business needs required

Demonstrated success in assisting with the preparing, filing, and completing of regulatory submissions preferred.

Personal skills

Leadership skills preferred

Ability to handle multiple high priority assignments preferred

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 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