The Regulatory Consulting Director will join a highly collaborative, friendly, passionate and energized team of professionals who work in an environment that goes beyond casual dress and flex scheduling. No structure or formality is permitted to get in the way of collaboration and teamwork. The ongoing growth of the company offers team members continuous opportunities to gain experience, develop skills and chart their course along an exciting success path.
Founded in 2007, PharmaLicense, LLC, a Two Labs business, originated with the intention of redesigning the approach to state licensure for pharmaceutical companies. Our team brings an organized, thorough and transparent approach to a very complex and evolving process. Our tools include electronic intake, closing checklists and state fee schedules, all coordinated through an overarching project plan to handle the entire process for our clients.
Reporting directly to the Senior Vice President of PharmaLicense, the Regulatory Consulting Director will work independently and as part of the team to serve as a pharmaceutical regulatory and state licensing subject matter expert. This position will directly support new sales, business development and expansion of business services & capabilities by PharmaLicense by assessing statutes and administrative rules, as well as regulatory agencies’ processes and procedures. The Regulatory Consulting Director will support PharmaLicense Account Managers in implementing client engagements as well as the licensing ops team in mitigating regulatory issues with state agencies.
- Business Development and Client Relations [60 % of time]
- Participate/lead state licensing sales presentations & new engagement kickoff presentations
- Identify and interpret new state regulations, create internal and external client communications
- Support due diligence and gap analysis projects for new clients in support of account manager’s strategy development and implementation
- Identify new regulatory requirements and build internal service capabilities
- Participate in client engagement projects at executive/c-suite level to address client regulatory issues
- State Laws and Requirements [approx. 40 % of time]
- Serves as subject matter expert for updates to statutes, administrative rules, and board guidelines
- Create and implement strategic plan to navigate licensure gaps, complex statue implications, and ongoing research needs
- Aggregate and research issues, draft analyses, and coordinate with General Counsel on interpretations and opinions
- Support Licensing Analysts in resolving statutory questions with state regulators
- Draft, submit and follow up on correspondence with regulatory agencies
- Document requirement changes / communicate to team
- Maintain database of all requirements; generate reports as needed
Desired Experience and Education
- J.D. / Law Degree strongly preferred
- Bachelor’s degree from four-year college or university, or an equivalent combination of education and work experience required
- 8-10 years regulatory research and analysis, legal, licensing or similar experience
- Consulting and/or business development experience a plus
Required Skills and Abilities
- Self-starter / ability to work independently and communicate with team members
- Critical thinking and analytical orientation, strong process orientation
- Outstanding written and verbal communication skills
- Superior attention to detail
- Reliability in fulfilling commitments
- Ability to cultivate extraordinary relationships with external and internal constituents
- Discretion in maintaining strict confidentiality
- Strong computer skills and be proficient in Microsoft Word, Excel, Power Point, Adobe Acrobat, and relational databases; Salesforce preferred
Additional Position Information
- Flexible hours; however, most work is typically performed during regular weekday business hours
- Telecommuting available following orientation period (in coordination with supervisor)
- On-the-job training, including pharmaceutical industry education
- Up to 20% travel possible
- Base Salary plus performance incentive bonuses
- Health Benefits and 401(k) plan
Two Labs, LLC is a non-smoking and drug-free workplace.
Two Labs, LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation or identity, national origin, disability status, or protected veteran status.