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Scientific Expert, Regulatory Affairs At Boehringer Ingelheim

Location: Burlington, Ontario

Job Description

Provides regulatory and scientific advice on ongoing and assigned projects to support local strategies and maximizing business potential. Supports the Regulatory Affairs team in ensuring Quality and Compliance for new human product development and registration activities in order to achieve and maintain New Drug registrations in line with local business priorities and needs, local laws, and regulations as well as with regional and global strategies, and in compliance with GCP (Good Clinical Practice), corporate policies and guidelines and SOPs

Responsibilities:

Innovation:

  • Recognized as an expert in their business area, providing strategy and advice and providing creative solutions to the Director and upper management within BI as needed (e.g. LOE cross functional team).
  • Contributing to the development and implementation of creative strategies for the presentation and negotiation of new drug submissions with Health Canada to ensure approvals are granted expeditiously and optimal labels are achieved for new products/indications.
  • Responds to Global Queries not related to a specific assigned product or a new product in development that has not yet been assigned to a team member.
  • Continually iterate and improve submission content based upon understanding of submission requirements and evolving needs and tools.
  • Actively seek, promote and implement new ideas/solutions by team to improve efficiencies in product registration and life-cycle management, while maintaining compliance to Guidelines and regulations, etc.
  • Participates in the development of concepts to align RA with internal functions to be best prepared for changes in the external environment (e.g. RA and Access).
  • Drives innovation activities related to RA e.g. Block chain in clinical trials, AI, etc...).

Scientific and technical support: Supporting RA team and cross functional teams

  • Provides accurate, complete, and objective assessment of described situations and submission strategies and assessment of risks through the identification, understanding, control and ongoing review of potential risks.
  • Provides scientific and technical guidance on the overall suitability of investigational and new drug submission documents including Pre-Submission meeting packages and summary reports, product Monographs, etc…
  • Identifies scientific and technical deficiencies and recommends action based on expertise as a scientist.
  • Responsible for recommendations directly influencing decisions on the technical adequacy of responses to critical Health Canada questions and queries.
  • Champions knowledge transfer to Project managers and Associates on new Therapeutic areas for BI, through being the point person and leading early phase development projects.
  • Provides secondary regulatory review and approval of digital and promotional materials submitted for the Docket Approval Process(DAP).
  • Develops and provides tracking tools to maintain oversight of RMPs, ASR, and safety communications to Health Canada and liaising with PV to ensure needs of PV are met (Spreadsheets, etc…).

Quality:

  • Reviews dossier content for investigational and new Drug Products prior to submission for completeness.
  • Ensures that submission content is in accordance with appropriate quality and compliance standards (legal, regulatory and company requirements).
  • CAPA lead and ensures completion of NC action plans.

Networking:

  • Establishes and maintains a close working relationship with RA staff and liaises effectively with internal departments (GRA, Legal, Marketing, Regulatory Affairs, Product Development, Operations, etc.) to ensure good working relationships.
  • Establishes external networks to drive innovative solutions as needed.

Participates in or leads special projects as assigned by Management (e.g. pipeline meetings with HC, compliance, LOE, etc...), and acts as back up to the team during absences when needed.

Qualifications:

  • Master of Science (M.Sc.) or higher degree in life sciences (e.g. pharmacology or pharmacy) with significant experience in Canadian drug regulatory environment.
  • Demonstrated experience in Regulatory Affairs in the Pharmaceutical Industry.
  • Thorough knowledge and understanding of Canadian federal and international regulations/guidelines concerning development, manufacturing and sale of therapeutic products.
  • Solid scientific knowledge, expertise and ability to review, analyze, and make recommendations on complex regulatory, business and operational issues as well as research projects.
  • Strong analytical aptitudes, skills and capacity to assess and summarize scientific data and regulatory situations
  • Excellent organization, time management, and written/verbal communication skills
  • Strong attention to detail and solid Project Management skills.
  • Good understanding of Quality related functions
  • Computer skills (i.e. Outlook, PowerPoint, Word, Excel, Adobe Suite), and familiar with digital technologies.
  • Exceptional interpersonal skills, ability to interact with key stakeholders
  • Strong problem solving and issue resolution skills
  • Self-motivated team player dedicated to accomplishing team goals
  • Extensive and ongoing awareness of the external environment including the industry, competitors and our products (product knowledge, Market knowledge, business knowledge).
  • Solid negotiation skills
Our Culture:

For more than 130 years, Boehringer Ingelheim – a research-based pharmaceutical company – has stood for the development of innovative medicines for people and animals.

Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.

Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.

The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 600 people across Canada.

For more information please visit www.boehringer-ingelheim.ca

Applications for this position will be accepted until July 20/2018

Job - Regulatory/Compliance
Primary Location - Americas-Canada-Ontario-Burlington
Organization - CA-Boehringer Ingelheim Canada Ltd/Ltee
Schedule - Full-time