Interested in joining our team?

Below are the currently available openings at Appili. Qualified candidates are invited to submit a cover letter and resume to Shirley Virga at svirga@grncalgary.com.

Director, Regulatory Affairs

Director, Regulatory Affairs will oversee the Global regulatory activities for assigned portfolios supporting Appili’s Vaccine and Anti-Infective Products

 

The Director, Regulatory Affairs is responsible for leading the development and implementation of Regulatory Affairs strategies and establishing optimal regulatory positions for new products and any existing commercial products.

 

RESPONSIBILITIES

  • Directs and develops regulatory group and/or teams across the company

  • Oversee and lead regulatory strategy and apply global perspective on product planning.

  • Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products; identify options and influence decision.

  • Directs efforts for planning and execution of required regulatory filings; oversee development of submission content and documents – provide guidance when appropriate.

  • Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure approvals are obtained.

  • Plan, prepare and execute for meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies and build rapport with regulators to best position for positive outcomes.

  • Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches.

  • Provide critical review of documentation supporting regulatory applications; analyze and resolve submission issues and identify new content as needed.

  • Ensure regulatory affairs activities are aligned to project timelines & business objectives and are compliant with ICH, FDA, HC, and EU regulations.

  • Maintain knowledge of regulatory environment, regulations and guidance.

  • Interact with company partners and consultants for various regulatory matters as needed.

  • Contribute regulatory perspective as needed on government proposals and external due diligence activities.

  • Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs; maintain currency and compliance with regulatory systems and understands external trends.

  • Identify and build external advocate network. Perform analysis to assess impact of new guidance & regulations on the portfolio.

  • Collaborate with business and technical groups on content of labelling.

  • Monitor key competitor positioning and determine impact to strategy.

  • Provide input into Regulatory Vision and develop operational plans.

  • May be responsible for department budget

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

EDUCATION, EXPERIENCE & SKILLS

 

Education:

  • B.Sc. degree in related biological and life sciences field (M.Sc. or Ph.D. preferred)

Experience:

  • 10+ years directly related experience in Regulatory Affairs, in biotechnology or pharmaceutical industry.

  • Knowledge of global regulations / guidance and thorough knowledge of biological/ drug development process required.

  • Must have knowledge and solid understanding of Health Canada, FDA and ICH regulatory requirements and procedures applicable to Clinical Research and Product Development.

 

Knowledge, Skills and Abilities:

  • Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.

  • Strong decision-making abilities

  • Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development,

  • Possess a broad knowledge of biopharmaceutical manufacturing and operations.

  • Demonstrated people-leader skills and evaluation of performance.

  • Ability to drive efforts, overcome obstacles and achieves results within budget and timeline specifications.

  • Ability to work in a highly diverse and fast paced, team environment.

  • Excellent written/verbal communication and interpersonal skills, as well as excellent computer skills required.

 

Additional Requirements:

  • Successful Completion of a Criminal Record Check.

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Senior Scientist, Clinical Research

The Senior Scientist, Clinical Research is responsible for:

  • Providing scientific expertise and clinical strategy to clinical development programs and oversee external clinical operations, biostatistics, data management and advise internal pre-clinical, bioanalytical, medical writing, regulatory affairs; 

  • Authoring relevant clinical trial documents; and

  • Playing a key role in the clinical development of the assigned product and the associated regulatory submission process.

 

Additionally, provides leadership by acting as a mentor to clinical research scientists and/or colleagues across the company.

 

RESPONSIBILITIES

  • Leads clinical research studies from trial design to final study report for assigned projects.

  • Develops, prioritizes and meets measurable short- and long-term objectives for assigned clinical studies.

  • Manages relationships with clinical consultants and/or relevant clinical research organization (CRO) personnel.

  • Provides guidance to relevant clinical research groups (eg, clinical operations, biostatistics, data management) involved in design and conduct of clinical studies.

  • Authors/reviews clinical trial protocols, investigator’s brochure, clinical study reports, clinical sections of regulatory submission documents including IND and BLA/NDS, developmental safety update reports, clinical overviews/summaries, clinical assessments.

  • Appropriately designs studies to meet desired clinical endpoints and with appropriate methods and measurements.

  • Reviews and applies current company SOPs. Revises relevant SOPs, when required.

  • Tracks progress of assigned clinical development programs and addresses problems as necessary

  • Collaborates with other internal departments and external consultants including pre-clinical, bioanalytical, medical writing, regulatory affairs, pharmacovigilance and corporate project management groups to ensure common goals are met.

  • Provides leadership/mentorship to clinical research scientists or to colleagues in other clinical research groups if applicable (eg, clinical operations, biostatistics, data management).

  • Presents internally for clinical trial/program training; externally (when required) to investigators/clinical trial site personnel (eg, site initiation visit, investigator meeting), data safety monitoring boards (DSMBs), at regulatory agency meetings, conferences and/or advisory boards.

  • Attends and contributes at regulatory meetings with FDA, Health Canada, EMA.

 

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

 

EDUCATION, EXPERIENCE & SKILLS

 

Education:

Qualified candidates will have one of the following: 

  • an advanced degree in Life Sciences or Medicine (PhD, PharmD or MD preferred) with at least 4 years of experience with a pharmaceutical company, CRO or other relevant clinical research institutions;

  • a Master’s degree in Life Sciences with at least 5 years of experience with a pharmaceutical company, CRO or other relevant clinical research institutions;

  • a Bachelor’s degree in Life Sciences with at least 6 years of experience with a pharmaceutical company, CRO or other relevant clinical research institutions.

 

Experience:

  • Must have knowledge and understanding of Health Canada, FDA and ICH regulatory requirements and procedures applicable to Clinical Research and Product Development.

  • At least 4 years of experience in the pharmaceutical industry with direct experience in designing and managing clinical studies.

  • Previous experience working in a matrix environment is highly desirable. Experience in clinical operations, biostatistics or data management is an asset.

 

Knowledge, Skills and Abilities:

  • Ability to drive efforts, overcome obstacles and achieves results within budget and timeline specifications.

  • Experience in presentations in public or regulatory settings. Excellent organizational, analytical, leadership, problem solving and interaction skills.

  • Ability to work in a highly diverse and fast paced, team environment.

  • Excellent written/verbal communication and interpersonal skills, as well as excellent computer skills required.

 

Additional Requirements:

  • Successful Completion of a Criminal Record Check.