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