Principle Regulatory Scientist - Combination Product Digital

This role provides strategic, tactical, and operational direction to expedite M.E. Pharmaceuticals’ drug delivery combination products and medical devices in development. This is achieved by interacting with teams and regulators to develop successful regulatory strategies and submissions in support of clinical trials and market clearance/registrations. The Principle Regulatory Scientist utilizes drug delivery system, medical device &/or digital health technical knowledge and regulatory expertise and lessons learned across Global Regulatory Affairs to drive internal consistency and influence effective change management. It is expected that this position embraces corporate transformation initiatives and represent GRA - Drug Delivery and Digital Health as a change ambassador. This is accomplished with a strong working knowledge of global regulations, guidelines and regulatory precedence coupled with a strong technical knowledge of device development process. This role is further accomplished by a demonstrated ability to establish and/or to promote / refine key regulatory positions and to effectively influence senior leadership on these positions.

Responsibilities:
The Research Advisor Scientist is recognized as an expert having broad technical knowledge of regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations.

• Independently develops complex global regulatory strategies and networks for alignment across GRA, R&D, Manufacturing sites and affiliates, as required, to enable timely completion of product registration milestones.
• Provide high quality, timely and decisive regulatory advice to allow product teams to make well-informed decisions on development or product lifecycle planning
• Anticipates and resolves key technical or operational issues that can impact the function, product team and/or submission timing.
• Networks independently with upper management and development teams, as appropriate, building awareness and alignment on complex Regulatory strategies, plans and risks.
• Creates and effectively manages input deliverables into timelines for development of device/combination product registrations, resolving major issues and conflicts via networking directly with development teams, and GRA senior management.
• Coordinating communication across GRA on drug delivery combination product and device support and developing forums for discussion and development of regulatory positions on new device standards and regulations.

Key Qualifications:

• Bachelor’s Degree in sciences, health or engineering discipline (e.g. biomedical engineering, engineering, pharmacology, chemistry, biology, biochemistry, pharmacy, or related scientific discipline)
• Medical Device and / or Pharmaceutical industry experience in clinical &/or technical product development (7 - 10 years)
• Prior experience authoring submission content incorporating complex regulatory strategies and leading FDA interactions
• Prior Regulatory experience (7 -10 years) or equivalent combination of technical and regulatory guidance knowledge.
• Demonstrated strong written, spoken and presentation communication skills
• Demonstrated leadership, negotiation, and influence skills • Demonstrates passion for developing Regulatory skills and capabilities in others
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles

Additional Skills/Preferences:

• Established relationships with CDRH / CDER reviewers, FDA policy groups, OCP, and/or DMEPA
• Knowledge and experience with connected drug delivery combination products and medical devices (including SiMD, SaMD)
• Demonstrated ability to apply critical thinking skills to solve complex problems through research and aggregating of information from various sources.
• Demonstrated ability to communicate to audiences of all levels and areas
• Demonstrated experience and continuous improvement of processes mindset
• Demonstrated learning agility
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Additional Information:

• Travel 10-15%
• Ideal if local to Indianapolis location, but may qualify for remote worker status