This individual will have accountability for the global regulatory department and will lead a team of highly qualified regulatory professionals in oversight and management of key regulatory functions including global regulatory operations, strategy, labeling, and medical writing.
Essential Duties and Responsibilities
• Accountable to lead the global regulatory strategy for the Company’s products (approved and pipeline).
• Provide counsel, training, and interpretation of global regulatory authorities’ feedback, policies and guidelines.
• Have oversight and accountability of the Company’s interactions with global regulatory authorities.
• Interpret, plan, and communicate requirements to ensure global marketing applications
• Oversight and accountability for medical writing and global regulatory operations.
• Ensure Investigative New Drug Applications and global clinical trial applications are cleared/approved.
• Lead and represent the Company before regulatory authorities together with regulatory professionals and subject matter experts.
• Interact with other functions, leaders and project teams in the preparation, review, and completion of global regulatory strategies and documents for regulatory submissions.
• Responsible for ensuring positive and proactive communications with the Leadership Team and Development Teams keeping them informed of regulatory statuses and significant regulatory issues, communicating risks and ensuring mitigations/contingencies.
• Able to oversee all project related regulatory strategy with all global project teams.
• Assure compliance with project team timelines and milestones for global regulatory deliverables.
• Oversee and accountable for the effective planning, organizing, and conduct of formal meetings with regulatory agencies including advisory committee meetings, oral explanations and other scientific and development meetings.
• On behalf of the Company represent the Leadership Team with an executive level presence when interacting with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of studies, CMC aspects, etc.
• Accountable for directly building and maintaining key external relationships across regulatory agencies and key stake holders.
• Responsible for cultivating a high performing regulatory team focused on accountability and meeting and exceeding expectations.
• Accountable for the Department/Functional Budget and Budget Management.
• additional duties and responsibilities not listed here may be required
Qualifications (Education & Experience)
• BS, MS, JD, MD, or Ph.D in a Life Sciences discipline or equivalent.
• Minimum of 15 years of experience in regulatory affairs and a minimum of 10 years of progressive leadership experience in the Pharmaceutical or Biotechnology industry.
• Strong leader, communication skills and proactive qualities and soft skills required.
• Able to think on your feet type- with great personality and self-driven to achieve success.
• Must be a go-getter and a doer and able to handle a face-paced, real-time aggressive work environment.
• Excellent phone skills for remote environment.
• Strong understanding of the drug development process.
• Familiarity with cardiovascular/metabolic drug development and regulatory requirements in major markets preferred.
• Extensive experience in cGMP and other Regulatory (CMC, preclinical) compliance requirements.
• Experience with global regulatory interactions and affairs including at least USA, EU, and JAPAC.
• Experienced team player with strong management and interpersonal skills to quickly gain confidence both with internal stakeholders and externally among regulatory agencies. Highly influential.
• An individual who can influence direction of complex regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
• Technical expertise to be a credible interface to all development and business partners (CMC, preclinical, clinical, statistician, business development, legal, etc.).
Skills Required
- BS, MS, JD, MD, or Ph.D in a Life Sciences discipline or equivalent
- Minimum 15 years regulatory affairs experience in Pharmaceutical or Biotechnology industry
- Minimum 10 years progressive leadership experience
- Extensive experience with cGMP, CMC, and preclinical regulatory compliance
- Experience with global regulatory interactions including US, EU, and JAPAC
- Proven ability to lead global regulatory strategy, submissions, and agency meetings (including INDs and clinical trial applications)
- Oversight experience for medical writing and global regulatory operations
- Strong leadership, communication, interpersonal and executive presence
- Ability to influence complex regulatory issues and represent company before regulatory authorities
- Technical credibility across CMC, preclinical, clinical, statistics, legal, and business development
- Responsible for department/functional budget and budget management
- Familiarity with cardiovascular/metabolic drug development and regulatory requirements in major markets
- Excellent phone and remote communication skills
What We Do
KMR Search Group is an executive search and recruitment firm specializing in the Healthcare, Pharmaceutical, Biotech, and IT Services industries. Operating with a nationwide reach, they help companies identify and place top-tier leadership talent in specialized roles, as seen in their history of conducting high-level searches for positions such as General Managers and Chief Financial Officers across various industrial sectors.
