Managing Director, Consulting Division (Regulatory Affairs)

Managing Director, Consulting Division (Regulatory Affairs)

September 15, 2022 By

Introduction:

Welcome to dicentra!

We are a diverse team from a wide range of industries and backgrounds all united by one common passion: to improve the health and wellness of people around the world. Whether we are developing and executing a break-through clinical trial, issuing the required certifications to sell a product in a new country or jurisdiction, or guiding a client to help them successfully navigate through regulatory hurdles, we do it with confidence, knowing that our team is backed by incredible and wide-ranging experience and one of the highest success rates in the business. If you share our passion for improving health and wellness and want to find purpose in your work, apply now and join one of North America’s most respected brands in both the Health Sciences and Food industries.

Let’s build a better world, together!

Why join us

Best workplace 
We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take work-life balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences.

Best people 
We unite cross-industry professionals with a shared passion for improving people’s health and wellness. Our inspiring leaders are accessible and work eagerly side-by-side with individual employees to help them understand and achieve their objectives.

Best opportunities 
We encourage our team members to continuously develop and enhance their skills and expertise. We recognize and reward courageous choices and innovative ideas that result in the growth of our people and company, and in the success of our clients.

Become a part of a purpose-driven and future-oriented business that impacts and improves millions of lives worldwide!

Responsibilities:

REGULATORY SUBJECT EXPERT
  • Directs the overall operational activities of Regulatory Affairs within Consulting Division for Canadian, US, and international clients for all product categories.
  • Coordinates the writing and updating of essential regulatory submission documents. Evaluates and reviews assigned regulatory files for completeness, internal consistency with other documents, and conformance to applicable Health Authority regulations.
  • Establishes and maintains relevant controls and feedback systems to monitor the ongoing operations of the Consulting Division. Oversees the development and implementation of strategies that ensure client compliance with appropriate domestic and international government agency regulations.
  • Liaises between clients and applicable regulatory agencies to ensure all stakeholders have accurate information and a clear understanding of all quality-related aspects of product registration.
  • Keeps up-to-date knowledge of Canadian and international regulations and provides the interpretation of regulatory requirements and guidance.
GROWING BUSINESS AND CLIENTS RELATIONSHIPS
  • Takes full accountability for growing the Consulting Division business by building and maintaining strategic business relationships and close contact with existing accounts to ensure long-term mutual cooperation and success.
  • Ensures the highest level of customer experience and increases their satisfaction level and loyalty. Cultivates a customer-oriented culture by coaching team members on exceptional customer service.
  • Obtains knowledge of client needs, concerns, and objections and offers global strategic advice to improve their business and ensure their success.
  • Identifies opportunities for business beyond initial service, offers additional services and global regulatory solutions and strategies to improve clients’ businesses and ensure their success. Leads the team towards a mentality of always offering clients an advanced level of global regulatory solutions and strategy.
  • Takes responsibility for internal communication, and ensures all clients’ requests are prioritized and their complaints are solved in a timely manner.
  • Oversees the forecasting and monitoring of account metrics for each client. Oversees the preparation of account reports as requested by clients or senior management.
  • Manages the portfolio of clients (in regulatory aspects as well as business aspects such as contracts and budgets).
TEAM MANAGEMENT AND LEADERSHIP
  • Plans, oversees, directs, and tracks billable time for the Consulting Division. Supervises technical team on time management and quotation, and ensures that procedures in place are geared towards maximum productivity and efficiency.
  • Helps create and maintain a culture that embraces change and growth, expands into new areas of expertise, and works towards continuous improvement and innovative solutions for clients.
  • Plans and oversees the allocation of resources to effectively staff and accomplish the work to meet the Division’s productivity and quality goals.
  • Reviews performance data that includes activities, financial & growth reports, and spreadsheets, to monitor and measure the Division’s productivity, goal achievement, and overall effectiveness. Prepares periodic reports for the senior leadership team, as necessary or requested, to track strategic goal accomplishment.
  • Overseeing team training needs and encouraging the team to partake in ongoing education.
  • Promotes a culture of high performance, a focus on continuous improvement, and a work environment that values learning and commitment to quality.
  • Inspires and motivates the team and contributes to growing future leaders.

Qualifications 

  • Bachelor’s degree in biomedical science, operations management, business administration, or related field; master’s degree preferred.
  • Minimum of 5 years of proven and progressive experience in a senior regulatory affairs role or in managing a complex and multifaceted operation.
  • Minimum of 10 years of progressive experience in a senior leadership position with demonstrated strong management, leadership, and motivational skills.
  • Excellent theoretical and working knowledge of people and operations management to optimize productivity and employee satisfaction.
  • Certification in regulatory affairs and quality assurance.
  • Excellent and effective interpersonal and communication skills, both verbal and written.
  • Excellent public speaking skills.
  • Strong budget development and financial and account reporting oversight skills.
  • Thorough understanding of general financial management and budgeting, including profit and loss, balance sheet, and cash flow management.
  • Ability to build consensus and relationships among peers, partners, and employees.
  • Proven ability to effectively delegate responsibilities while defining and maintaining organizational control of operations and client service.
  • Competent collaborator and skilled cross-functional communicator.
  • Experienced in conflict management and business negotiation processes.
  • Working knowledge of general business, project and management software, relational databases, and aptitude to learn new applications; proficiency in Microsoft Office (Word, Excel, Outlook). High-quality standards, responsibility, and engagement.
  • Ability to interact with a range of personalities and all levels of the organization and work cooperatively in a team environment.
  • Demonstrated self-motivation and the ability to take initiative.
  • Excellent project management and strong prioritization skills.
  • Attention to and ability to execute details.
  • Ability to adapt to and implement change effectively and facilitate its acceptance by others.
  • Proven ability to think strategically and to develop clear action plans to align with and ensure delivery of the division’s strategy and goals.
  • Proven ability to manage relationships and communications with vendors, review and monitor study performance/metrics, and plan, implement and execute projects.
  • Excellent analytical and problem-solving skills (recognizing, analyzing, and resolving).
  • Excellent decision-making skills with the ability to form/defend/articulate independent judgments in assessing difficult situations.
  • Excellent organizational and time management skills to work effectively and efficiently while demonstrating composure under pressure/stressful conditions to meet multiple, concurrent, and competing deadlines and priorities.
  • Displays the highest degree of integrity.

In addition to the skills and qualifications above, we value the following qualities in all of our team members:

  • Ability to work independently with little supervision or as a team.

  • Willingness to take on challenges and learn in an ever-changing regulatory landscape.

  • Proficiency in using MS Office applications.

  • Strong attention to detail.

  • Strong problem-solving skills.

  • Strong verbal and written skills.

  • Ability to manage and prioritize tasks in a fast pace, hard-deadline environment.

  • Willingness to travel to client sites as needed.

Job Type: Full-time.  

Location: Toronto, ON office.

Applying:

To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com with “Managing Director, Consulting Division (Regulatory Affairs)” in the subject line.

As part of the hiring process, in addition to interviewing, successful candidates may be required to complete a skills assessment and a reference/background check. If you are sent a skills assessment, please complete it for consideration for the advertised position.

We thank all applicants for their interest, however, only those selected for an interview will be contacted.