Senior Director of Regulatory Affairs

2 days ago


Parsippany, New Jersey, United States Melinta Therapeutics Full time
Job Title: Senior Director of Regulatory Affairs

Melinta Therapeutics is a biopharmaceutical company dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. We are seeking a highly experienced Senior Director of Regulatory Affairs to provide strategic leadership and formulate comprehensive regulatory strategies for product development and life cycle management of approved products.

Responsibilities:
  • Provide high-level strategic leadership and direction for regulatory activities, including submission preparation, defense, and interactions with regulatory authorities.
  • Oversee and interpret regulations, guidelines, procedures, and policies related to the development and global registration of drug products.
  • Lead and advise regulatory and clinical teams, providing expert guidance on submission and dossier requirements.
  • Act as the primary point of contact with regulatory authorities, fostering strong working relationships with internal clinical team partners and external CROs.
  • Develop and implement comprehensive regulatory strategies and operations, ensuring timely delivery of all regulatory submissions.
  • Provide regulatory insights and input into new business venture activities, contributing to strategic decision-making.
Requirements:
  • Full lifecycle experience from early development to managing marketed products.
  • Strong project management and computer skills, including Microsoft Office.
  • Demonstrated strong leadership and management skills, with a proven ability to work with minimal supervision.
  • Global regulatory management experience.
  • Knowledge of Global Labeling Guidance, Drug Development, and Commercialization of prescription medicines.
What We Offer:

Melinta Therapeutics offers a dynamic work environment, where innovation, teamwork, knowledge, and flexibility are valued. We strive to provide a range of solutions that meet the need for treating serious infections. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.



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