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Senior Director, Regulatory Affairs

Posted Jun 10
Full Time
Parsippany, New Jersey

SENIOR DIRECTOR, REGULATORY AFFAIRS

Melinta Therapeutics is a biopharmaceutical company with strong commercial and medical capabilities dedicated to providing innovative therapies to people impacted by acute and life-threatening illnesses. Melinta’s current portfolio includes seven commercial stage products and one investigational product under review by FDA: BAXDELA® (delafloxacin), KIMYRSA® (oritavancin), MINOCIN® (minocycline) for Injection, ORBACTIV® (oritavancin), REZZAYO™ (rezafungin for injection), TOPROL-XL® (metoprolol succinate), VABOMERE® (meropenem and vaborbactam), and cefepime-taniborbactam. With an unsurpassed commitment to providers and patients, Melinta is dedicated to saving lives threatened by the global public health crisis of infections. We are small but mighty, with an unsurpassed commitment to patients, one another, and the business. We strive to offer a dynamic work environment, in which innovation, teamwork, knowledge and flexibility are valued.

Melinta’s portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. Visit www.melinta.com for more information.

Overview Of Responsibilities

The Senior Director of Regulatory Affairs provides strategic leadership and formulates comprehensive regulatory strategies for product development and life cycle management of approved products, ensuring ongoing compliance with applicable regulatory requirements. This role is pivotal in facilitating proactive and effective interactions with regulatory bodies to secure timely and favorable regulatory decisions.

Responsibilities

  • Provides high-level strategic leadership and direction for regulatory activities, including submission preparation, defense, and interactions with regulatory authorities for new and ongoing clinical and surveillance programs, including labeling negotiations
  • Oversees and interprets regulations, guidelines, procedures, and policies related to the development and global registration of drug products, with a specific focus on clinical development and global registration
  • Leads and advises regulatory and clinical teams, providing expert guidance to clinical CROs, regulatory vendors, and area authors/reviewers on submission and dossier requirements
  • Acts as the primary point of contact with regulatory authorities, fostering strong working relationships with internal clinical team partners, project consultants and contractors, and external CROs
  • Develops and implements comprehensive regulatory strategies and operations, ensuring timely delivery of all regulatory submissions
  • Creates and executes detailed regulatory submission project and resource plans, sets goals, and tracks progress towards critical milestones for major regulatory submissions
  • Provides regulatory insights and input into new business venture activities, contributing to strategic decision-making
  • Effectively addresses and resolves regulatory authority and business partner questions and concerns, ensuring compliance and alignment with business objectives

Education

Bachelor's degree or equivalent in life sciences or related discipline

Qualifications

  • 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; proven ability to work with very little guidance/supervision with a proactive approach
  • Global regulatory management experience
  • Knowledge of Global Labeling Guidance, Drug Development and Commercialization of prescription medicines
  • Highly collaborative and works with ease in matrix environment
  • Minimum of 10 years pharmaceutical experience 8 years regulatory experience in in drug development and registration activities

Position Type

Full Time

Location / Travel

New Jersey home office preferred (Hybrid), with travel as required

Melinta Therapeutics appreciates your interest in our company as a place of employment. It is our Company's policy to employ, retain, promote, terminate and otherwise treat all employees and job applicants without regard to any individuals’ age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws