Regulatory and Scientific Manager

Regulatory and Scientific Manager

August 10, 2021 By

Introduction:

dicentra is currently looking for a motivated and client-focused Regulatory & Scientific Manager to join our growing team. The successful candidate will develop, propose, and implement well-informed global regulatory strategies in a highly cross-functional, collaborative, project team environment. This role is about ensuring compliance of all products categories regulated by appropriate domestic and international government agency regulations.

Apply now and help us 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!

Job Responsibilities:

  • Develops, proposes, and implements global regulatory strategies for assigned multidisciplinary projects in all stages of development by following overall product development plans.
  • Works with business partners, external experts, CRO’s and internal colleagues to align on global regulatory strategy and coordinate regulatory submissions.
  • Serves as back-up contact with US Food and Drug Administration (FDA) and Health Canada, and liaises with other country Regulatory Agencies when needed to ensure all stakeholders have a clear understanding of all scientific and regulatory-related aspects throughout product registration as well as to ensure timely resolution of issues and the approval of regulatory applications.
  • Provides interpretation of regulatory agencies’ feedback, policies, and guidelines to internal colleagues. Keeps up-to-date with current regulations, guidance, and interpretations and notifies appropriate personnel as needed.
  • Maintains products compliance through the entire product life-cycle, from product development/formulation to post license changes, as applicable to the product classification
  • Reviews/develops and substantiates marketing and scientific claims as appropriate to the product classification.
  • Completes scientific safety assessments and dossiers as required for the product type (GRAS, NDIs, food additive submission, novel food, etc.).
  • Develops, reviews, and maintains company-wide and departmental policies and SOPs.
  • Identifies potential regulatory risks to the strategic and operational plans and proposes options to mitigate risks.
  • Monitors budgeted hours and ensuing projects are completed in an appropriate time frame.
  • Performs as Account Manager for multiple clients.

Job Qualifications:

EDUCATION AND EXPERIENCE

  • Bachelor’s, Master’s, or Ph.D. in a scientific, medical, or regulatory discipline.
  • Specific knowledge, skills and/or licenses or certificates (such as Regulatory Affairs Certification) are highly desirable.
  • Minimum of 7 years Regulatory Affairs experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment required (experience working for a consulting firm highly desirable).
  • In-depth knowledge of Canadian, US, and international regulations for all products categories.
  • Demonstrated hands-on experience in managing and preparing regulatory submissions (including NDAs and/or European MAAs) and a demonstrated track record of successful regulatory submissions.

SKILLS AND REQUIRED COMPETENCIES

  • Excellent analytical abilities and strategic thinking.
  • Understanding risk management and ability to develop global risk assessment scenarios prior to functional and team reviews.
  • Great attention to detail and ability to execute details in order to successfully oversee regulatory initiatives.
  • Well-developed presentation and communication skills (oral, written, computer-proficient) with the ability to present ideas, solutions, and strategies in a clear and concise manner.
  • Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects.
  • Self-motivation and the ability to take initiative.

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 problem-solving 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: Opportunity to work remotely or in Toronto, ON office.

Benefits Include:

  • Disability insurance
  • Dental Care
  • Extended health care
  • Life insurance
  • Vision care
  • Wellness program
  • Work remotely/optional

Applying:

To be considered for future opportunities, please email your cover letter, resume/CV, and any related supporting documentation to hr@dicentra.com with “Regulatory and Scientific Manager” 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.