Regulatory Operations Lead

MMS Holdings Inc. - Denver, CO

Full-timeEstimated: $93,000 - $130,000 a year
Skills
MMS is an award-winning, data-focused CRO that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating and was named as the Best Global Biotech CRO in the 2018 International Life Sciences Awards. For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

Roles and Responsibilities:
Provides guidance for the team(s) responsible for global submissions including the compilation, preparation, review and submission to Health Authorities
Assists in strategic planning activities and translation of strategic decisions into operational plans related to all areas of regulatory operations
Provides oversight to ensure processes are in place for the publishing of regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission ready standards
Ensures submission project plans are created and maintained
Ensures deliverables align with applicable regional, ICH, company and client defined standards
Creates high quality project deliverables that are released to clients
Maintains technical expertise of regulatory requirements and ensures alignment with company processes and client requirements
Identifies resources and technologies as needed to support submission activities and to resolve identified issues and risks
Provides guidance for process updates due to changing regulations that impact submission strategies and technologies
Acts as a resource to project teams to provide guidance in producing high-quality client deliverables
Demonstrates excellent internal and external leadership skills
Practices excellent internal and external customer service
Produces and presents external company presentations providing industry visibility for the organization
Serves as MMS point of contact with clients for regulatory issues as needed.
Contributes to defining project scope, timelines and potential resources needed to meet client requested services
Identifies risks and opportunities and addresses as needed with a focus on customer satisfaction
Requirements

Graduate degree preferred in related discipline/ industry
10+ years of experience in pharmaceutical or CRO industry required
Experience leading pre- and post-approval marketing applications (both NDA and MAA)
Strong knowledge of current and upcoming Health Authority regulations, particularly related to data standards and exchange
Working knowledge of ex-US submissions (CTA and MAA), including EMA, Health Canada, and Australia
Proven track record for strategic design and implementation of new services, especially within a changing regulatory environment
Experience with data and document transparency initiatives
Work in conjunction with project management and business operations to build opportunities, enhance collaboration, and increase networking with existing and potential new clients
Lead cross-functional teams and partnerships in support of goals that affect colleagues in all regions
In-depth understanding of regulatory submissions processes, clinical development and operations implementation and management, the drug development process and regulatory guidelines
Proficiency with MS Office and SharePoint applications
Self-motivated with excellent skills in multi-tasking, attention to detail and follow-through
Excellent organizational, project coordination and communication skills
Familiarity with ISO 9001 requirements
Ability to anticipate and effectively resolve potential issues and client requests
Global regulatory experience, INDs/CTAs, working with Ethics Committees and good understanding of global regulatory submission requirements
Experience with startup activities such as being involved during an initial IND
Experience at CRO preferred but not required