Regulatory Compliance Specialist

2 weeks ago


Raleigh, North Carolina, United States Merz Therapeutics Full time

Regulatory Affairs Specialist

Merz Therapeutics is in search of a Regulatory Affairs Specialist to oversee regulatory functions associated with the life cycle management of pharmaceutical products. The successful candidate will play a key role in managing regulatory timelines and submissions to relevant health authorities, ensuring compliance with industry standards.

Key Responsibilities:

  • Facilitate regulatory submissions for lifecycle management activities, including annual reports, safety documentation, CMC, and product labeling.
  • Engage with regulatory agencies, contract manufacturers, affiliates, and distribution partners.
  • Stay informed about regulations and guidelines pertinent to the company's operations and products.
  • Assist in the preparation and submission of labeling supplements.
  • Provide support to other regulatory personnel as necessary and undertake additional responsibilities as required.

Qualifications:

  • Bachelor's degree is required, ideally in a Scientific or Health-related field.
  • A minimum of 1-2 years of pertinent regulatory experience is preferred.
  • Proficiency in Microsoft Office applications is essential.
  • Strong organizational, communication, and attention to detail skills are necessary.
  • Ability to prioritize tasks and manage multiple responsibilities effectively.
  • Demonstrated experience in preparing, filing, and completing regulatory submissions is advantageous.
  • Leadership capabilities and the ability to manage several high-priority assignments are preferred.

Merz Therapeutics is dedicated to fostering a diverse and inclusive workplace. Candidates who may not meet every qualification are still encouraged to apply, as they may possess the right attributes for the role. Merz Therapeutics is an Equal Opportunity Employer.



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