Director, Regulatory Affairs and Compliance

Employment Type

: Full-Time

Industry

: Miscellaneous



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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 & Responsibilities:

  • Oversee and lead the Regulatory Affairs and Regulatory Compliance departments.
  • Provides strategic regulatory input and technical guidance on regulatory requirements to project teams and clients including monitoring the impact of changing regulations on submission strategies and updates, providing regulatory strategic input on regulatory applications and clinical development plans, and overseeing the publishing of regulatory submissions according to ICH guidance Represents Regulatory as the primary contact on global regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective/considerations at a project level in team meetings.
  • Demonstrates an excellent understanding of country requirements for investigational and marketing applications, i.e. INDs, NDA/BLAs, IMPDs, CTAs and MAAs - overseeing the planning and execution of those applications and subsequent submissions to regulatory authorities within company timelines and in accordance with regulations and guidelines.
  • Gives advice on harmonization of US and Global submissions (e.g., VHP, coordinated IND and IMPD writing, management of IB and Protocol amendments across regions, etc.).
  • Coordinates with clinical CROs and local Authorized Agents on global regulatory submissions (overarching PM, managing versioning, coordinating responses to queries and information requests).
  • Responsible for working with internal and external teams, as well as vendors, to manage short- and long-term global regulatory activities that support the success of investigational and marketed pharmaceutical products throughout their lifecycle, including the compilation, preparation, coordination, review, and submission to Health Authorities.
  • Observe and adhere to applicable regulatory and legal requirements, including participation in impact assessments for MMS/clients for any regulatory updates.
  • Cooperate with other company departments to optimize global efficiency.
  • Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking and other pertinent information.
  • Understand business concepts and uses strategic processes to make good business decisions.
  • Serve as MMS point of contact with clients and internal teams for matters relating to contractual requirements, deliverable changes, timelines, and deliverables.
  • Develops and maintains SOPs, work practices, forms and other documentation and training materials related to regulatory affairs and regulatory compliance services.
  • Travel to client sites as necessary.
  • Actively promote new business by participating in project bids and client presentations as appropriate.
  • Strong project management knowledge, including complex projects with multiple team members and independent coordination with the client.
  • Lead the effort to determine stakeholders’ needs and ensures business value is realized.
  • Compliance

  • Demonstrate a strong understanding of standards, guidelines, and FDA regulations and takes initiative to suggest and implement process improvements and follows through to completion.
  • Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.
  • Software/ Programs

  • Demonstrate extensive knowledge of departmental processes and demonstrate competency with necessary software.
  • Managing

  • Work with management and stakeholders to identify priorities, goals, and milestones.
  • Identify future risks and provide solutions before the risks become a barrier to producing quality deliverables on time.
  • Ensure the departmental goals are met and are in line with company goals.
  • Responsible for supporting the development and execution of both short and long term recruitment strategy to ensure the company’s growth including providing hiring recommendations of personnel.
  • Provide leadership, mentorship, and develop personnel by maintaining a positive work environment.
  • Responsible for professional development of colleagues.
  • Work with senior management in developing managers and ensuring a talented pipeline of management staff within the department.
  • Work with management in other departments to develop business initiatives and process improvements across the organization; solution focused.
  • Monitor staff projects quality, timeliness and budgets to foresee and correct issues and assure project expectations are met.
  • Gather and monitor key metrics to assess project performance.
  • Effectively assign and communicate priorities and works direction to ensure completion of assigned tasks on time and within budget.
  • Demonstrate extensive knowledge of departmental processes and mentors personnel.
  • Lead and implement departmental process improvements.
  • Job Requirements

  • Graduate degree in scientific, medical, clinical discipline or related field, or related experience.
  • At least 7 years of experience in a CRO environment and experience with Regulatory and Compliance Services.
  • Excellent organizational, communication, negotiation, problem-solving, analytical and consulting skills.
  • Technical leadership and contribute to a high performing team.
  • Expertise in optimizing trial design, development programs, submission strategies and regulatory interactions.
  • Outstanding understanding of the drug, device or diagnostic development process.
  • Expertize in broad different therapeutic areas and indications.
  • Thorough understanding of regulatory guidance and practices pertaining to submissions and approval processes.
  • Thorough understanding of ICH/ GCP guidelines.
  • An ability to assess situations and make and carry through difficult decisions.
  • Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions).
  • Demonstrable experience of stakeholder/ relationship management with a client focused approach to work. Able to understand the business implications of decisions and impact on customer.
  • Advanced ability to manage multiple and varied tasks across multiple-projects with enthusiasm and prioritize workload with attention to detail.
  • Advanced ability to work in a matrix environment and to value the importance of teamwork.
  • Comprehensive knowledge of relevant software: Windows, Word, Excel, Outlook, etc.
  • Has an established track record of problem-solving and troubleshooting including significant regulatory and decision-making support at a program level.
  • Is effective in the use of relevant computational tools for study, experiment, or trial research objectives.
  • Demonstrated ability to effectively collaborate and influence throughout multiple levels of the organization.
  • Experience in regulatory interactions and submissions.
  • Significant experience in the pharmaceutical industry, with broad clinical development and therapeutic area knowledge.
  • Familiarity with current ISO 9001 and ISO 27001 standards preferred.
  • Familiarity with 21 CFR Part 11, FDA, and GCP requirements.
  • Understanding of CROs and scientific & clinical data/terminology, & the drug development process.
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