Director, Regulatory Strategy

Company Overview:

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.

Our mission to deliver innovative, life-saving medicines for serious unmet medical conditions drives us every day and contributes to building a sustainable business for the long term. It also inspires our entrepreneurial culture which fosters innovation, collaboration, and a relentless commitment to the people we serve. Patients are at the center of everything we do because everyday matters. Every employee is encouraged to take initiative, explore new ideas, and turn challenges into opportunities that can potentially transform lives, especially those suffering serious, difficult-to-treat illness

Our products marketed in the U.S. include:

GIAPREZA® (angiotensin II) is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.

XACDURO® (sulbactam for injection; durlobactam for injection) is a new treatment designed specifically to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex in adults.

XERAVA® (eravacycline) is a broad-spectrum antibiotic used to treat patients with complicated intra-abdominal infections (cIAI).

Our latest addition to the Company's expanding antibiotic portfolio is ZEVTERA® (ceftobiprole), a newly approved advanced-generation cephalosporin antibiotic. ZEVTERA is the only FDA-approved cephalosporin specifically designed to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI), adult patients with Staphylococcus aureus bloodstream infections (bacteremia) including those with right-sided infective endocarditis, and adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP). We anticipate a U.S. launch in mid-2025.

Innoviva Specialty Therapeutics development pipeline includes zoliflodacin, an investigational first-in-class oral antibiotic being developed for the treatment of uncomplicated gonorrhea infection in patients.

At Innoviva Specialty Therapeutics, Inc., we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make a difference.

Summary of Position:

The Director of Regulatory Strategy (Global Regulatory Lead/GRL) will be responsible for the design and implementation of short and long term global regulatory strategies for the programs under his/her accountability. The role will be responsible for the development as well as life cycle management strategies for the assigned programs at Innoviva Specialty Therapeutics (IST). This role will have high visibility with the IST Leadership Team with a significant impact towards the success and achievement of the business and corporate goals.

Responsibilities:

• Represents Global Regulatory Affairs as a core member of the cross functional strategy teams (Development Strategy Teams/Product Strategy Teams) and provides overall regulatory strategy and guidance for the program(s) globally. In this capacity, the GRL is the single point of contact for the business on regulatory issues for the assigned program(s).
• Ensures the development and implementation of robust global regulatory strategies/position for their assigned programs and will be accountable for presenting these to the executive leadership team as required. This includes creation and submission of regulatory documents (e.g. IND/CTA submissions, NDAs, and other relevant regulatory submissions)
• Collaborates transversely with other members of Regulatory Affairs (including Reg Ops, Reg CMC) to ensure a cohesive and robust regulatory strategy/plan
• Partners with the labeling strategist to ensure appropriate labeling content based on the target product profile
• Provides proactive guidance to internal program teams based on technical and regulatory knowledge towards development of strategic and tactical plans
• Identifies and assesses regulatory risks associated with product development for assigned products and work collaboratively with cross-functional program team to develop mitigation strategies
• Ensures timely communications of relevant topics to the business and up through Head of GRA. The communication of any HA feedback should be interpreted and the impact on the project assessed
• Researches and analyzes regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
• Effectively lead health agency meetings to ensure full discussion of issues and opportunities
• Serves as the primary point of contact with the FDA, depending on program assignment, to develop an effective professional relationship and promote a positive company image
• Provides vendor oversight to ensure efficient and successful execution of regulatory processes and submissions
• Assists with regulatory inspection activities, as needed
• Ensures compliance with all internal and external requirements and procedures and suggests improvement to operating policies/processes, as appropriate
• May be responsible for creating and reviewing regulatory operating procedures and policies, if necessary
  
  
  

Experience & Education:

• Bachelor of Science in a scientific discipline. Advanced degree is preferred (MS, PhD,) MD, PharmD, JD
• 10 plus years of pharmaceutical industry experience; inclusive of at least 8 years of Global Regulatory Strategy experience
  
  
  

Skills and Abilities:

• Direct interaction/negotiation with global regulatory authorities (e.g. FDA, EMA)
• Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
• Expect empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward innovative and optimal regulatory strategies and implementation
• Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
• Excellent operational skills including planning, organizing and ability to motivate and lead others
• Strong attention to detail in composing, proofing materials, establishing priorities, scheduling, and meeting deadlines
• Can demonstrate solid oral communication and writing skills
• Understanding of the Global (US, UK and EU in particular) and U.S. pharmaceutical marketplace and familiarity with medical terminology
• Experienced in responding to health agency queries or complaints
• Develops collaborative cross-functional relationships to facilitate the accomplishment of work goals
• Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
• Can build networks to obtain cooperation without relying on authority
• Strong ethics, professional integrity, and personal values consistent with IST core values
  
  
  

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.