The successful candidate will work with a cross-functional team to implement regulatory strategy, data and submission packages to US and international regulatory agencies. Reporting directly to the Senior Director of Quality, the responsibilities include actively contributing to the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on project teams, active involvement in the writing and review of regulatory submissions and interfacing with authorities, coordinating all aspects of regulatory submissions and proactively keeping updated on regulatory requirements worldwide.
What you'll do
Responsibilities included, but are not limited to:
- Provide interpretive regulatory opinions, policy, guidance and strategies to ensure that development of new products result in expeditious approvals, meet regulatory requirements and fully exploit the capabilities of the new compound;
- Represent the company as the responsible official for all phases of regulatory submissions;
- Negotiate and obtain agreements on behalf of the company at meetings with regulatory agency officials at director levels or above;
- Provide innovative and strategic regulatory leadership to project teams in early and late stage clinical development for orphan diseases.
- Work proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners to plan and execute an effective global regulatory strategy in alignment with the overall clinical development plan.
- Lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle, including briefing documents, INDs, and various designation requests
- Lead the planning, strategy, content and execution of NDA/BLA filing and follow through to approval
- Identify potential regulatory risks to the strategic/operational plans, and propose options to mitigate risks
- Prepare the team and lead negotiations with FDA and other health agencies
- Provide regulatory due diligence as required
- Supervise and mentor direct reports who will be managing other programs, if applicable.
What you'll need
Minimum qualifications you must possess to be considered for this role:
- B.Sc. in a related science
- 7-8 years of experience working in Regulatory Affairs; preferably 2+ years in biotechnology and at least 1 - 3 years in a supervisory role.
Preferred qualifications for this role:
- M.Sc. or Ph.D. in a related science.
- 10+ years of experience working in Regulatory Affairs; ideally 2-5 yeras in the biotechnology industry and at least 3 - 5 years in a supervisory role.
- Regulatory Affairs Certificatio (RAC) (Canada/US)
- Must have expert knowledge of all appropriate regulations, especially as they apply to preclinical and clinical disciplines to support filings in the US and Canada.
- A thorough working experience in a regularotry affairs department with knowledge of FDA and Health Canada divisions, personnel, and procedural concepts.
- Successful submissions and approval, and post-approval management of IND/NDA/BLA/MAA/NDS in Canada and the U.S.
- Experience interfacing with FDA (CBER) and Health Canada (BGTD).
- Sucessful contribution to a major regulatory approval at a global level.
- Prior staff management of several personnel.
- Proficient in various type of computer software (Word, Excel, PowerPoint & Outlook).
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal and external teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
- Experience in orphan drug development and/ or rare disease indications desirable.
- Regulatory Affairs Certification an asset.
- Knowledge of relevant international regulations and standards related to submission of combined therapies.
- Experience with immuno-oncology and combined therapy submissions. Demonstrate strong team-building skills.
- The ability to work within a global team framework and a multi-cultural environment.
We're looking for
A little bit about us
Strong Science Needs Bright Minds
At Immunovaccine, we have high standards. And even higher aspirations.
Our drug candidates are helping us build on this promise. Our technology provides the tools that underscore this mission. And our people are the heart of our operation–the ultimate value-drivers upon which we, as a Company, rest.
We Work Better Together.
Curing diseases-especially the ones that continue to evade and outpace even the brightest minds in our industry-is hard work. Despite the intensity and ferocity of our business, the one thing we do not have to worry about is the morale and the spirit of our people. We work hard and we play hard. Our people enjoy our drive, our mission and the road less traveled here in Halifax. As it turns out, that does make all the difference.
We aim high with our mission, so we expect high performance from our people. Whether you are evaluating T cell responses, coordinating clinical operations with our partners, or working with our investor base, we depend on you to help realize the full value of our organization. In turn, we value you, and what you can bring to our Company. We support you in enjoying life fully while working towards your professional goals. Above all, we cultivate the camaraderie that is the hallmark of our corporate culture.
Happy Employees Produce Strong Results.
Talk to us about joining the Immunovaccine team.
Are you interested?
Work With Us
Our head office is on Summer Street in Halifax, Nova Scotia and we have an office in Quebec City, Quebec. This role will work out of our Halifax, Nova Scotia office. A remote position will be considered for persons with sufficient experience. The normal work week is 35 hours, core hours being 9 am – 5 pm. This role will very occasionally see early mornings, weekend work and/ or extended hours depending on the project underway at the time. You will spend most of your time sitting in an office environment. Distance travel is not expected for this position, unless the position is based remotely. If this occurs, inclusive of professional development opportunities, we expect approximately 20% of your time to be spent in Halifax.
Salary and Benefits:
This will be a salaried position. Please indicate clearly on your application your desired salary for this role.
Compensation will be determined based upon skill set and experience of the selected candidate and benchmarking for the position. Immunovaccine offers paid vacation, health/ dental plan, employee assistance program, stock options, annual bonuses and cost of living increases to eligible employees.
If you feel that you are the best candidate for this position, please apply through the “Apply Now” button.
Please clearly indicate in your application how you meet the requirements for this role, and why you think you would be the best candidate for the role.
Applications will be considered until the competition close date of October 20th, 2017 at midnight.
*We appreciate your application but only candidates selected for interviews will be contacted. We reserve the right to request interview candidates to complete skill/ behavior based assessments as part of the interview process.
** The successful candidate will be required to provide a Criminal Record Check before their start date.
Immunovaccine Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops cancer immunotherapies and infectious disease vaccines based on the Company’s DepoVax™ platform, a patented delivery agent that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as part of a triple combination therapy in ovarian cancer, as well as a Phase 2 study in recurrent lymphoma. The Company is also advancing an infectious disease pipeline, including innovative vaccines for respiratory syncytial virus (RSV), and currently has clinical projects ongoing to assess the potential of DepoVax™ to address malaria and the Zika virus. (Connect at www.imvaccine.com.)