Profile

Diverse professional with over ** years experience in Drug Regulatory Affairs

-Extensive, progressive experience in various technical environments, specializing in the Pharmaceutical Industry

-Successful track record of delivering time-critical projects (e.g. submissions) within deadlines

-An experienced team player who naturally assumes a leadership role when needed

-A skilled mentor and self starter; recognized for high-quality, autonomous work

-Very strong organisational, multi-tasking and problem-solving skills

-Solidly analytical, with the ability to set priorities, delegate and motivate staff

-Well developed interpersonal communication skills - works confidently with top management

-Conversational French

Knowledge, Skills and Competencies

Drug Regulatory Affairs:

Technical and General Knowledge Skills

Maintained high level of technical knowledge of Canadian and international requirements as well as internal local and global processes, systems and standard operating procedures

Submission Project Management

Planned and conducted all activities related to the preparation, review and production of all types of submissions (i.e. CTAs, NC, Level III & IV In-House updates, Administrative NDS, annual DIN, etc) to meet Health Canada format requirements and regulations

Executed all activities related to eCTD submissions (building, publishing, hypertext linking), lifecycle management of dossier (sequences) and documents (attributes)

Quality Control

Ensured quality of all submissions in compliance with Health Canada, ICH and corporate guidelines

Customer Focus and Stakeholder Interaction

Interacted, consulted and collaborated with internal colleagues (regulatory, clinical, foreign markets) and key external customers (CROs) on policy and regulatory guidance requirements

Developed and executed continuous improvement processes to optimize departmental effectiveness and efficiency

Database and Records Management

Provided site, account and data management of local and corporate databases, systems, and applications to support departmental business objectives (i.e. eCTD shared drive, ISI, GDMS, GRS, IRIS, BRIO, eCCNET, Rosetta, Impala, Clinicopia, Clinphone, CSDS and LAN, etc). Lead and optimize local Product Monograph process

Clinical Operations

Responsible for the timely review and approval of country related submission packages (US and Canada) in accordance with ICH, GCP and all applicable regulations, laws and other ethical and quality standard guidelines.

Responsible for the review and approval of site level critical documents for Investigational Product (IIP) release in accordance with regulatory/sponsor requirements – within specific timelines and quality standards.

Ensured the review and finalization of site specific Informed Consent forms were in accordance with site and sponsor specifications.

Responsible for the update of the clinical trial databases (CTMS), and for clinical supply and non-clinical supply management.

Executive Office Administration

Over 22 years of executive level administrative support experience

Experience as a Personal Assistant requiring a high level of discretion, capability and organization; managed personal bills, bank account transactions, household issues and staff

Handled a wide range of office responsibilities such as: travel management, expense reporting, event planning, meeting and conference scheduling, corporate sponsorship and donations, trademark applications and renewals, operations and project cost tracking, budgeting and forecasting, corporate car and credit card program, as well as regular day to day administrative activities

Supervised word processing department and receptionist

Professional Experience

1999 – 2014

PFIZER CANADA INC.

Drug Regulatory Affairs

Specialist, Submission Management Sciences

Compliance and Systems (2010 – 2014)

Submission Coordinator (1999 – 2010)

1993 - 2000

IMS HEALTH CANADA

Finance and Administrative Services

Administrative Assistant to the President

Administrative Assistant to the Vice President

1991 - 1993

CHAPTER THREE MARKETING RESEARCH SERVICES INC.

Administrative/Personal Assistant to President

Administrative Assistant to Vice President

Supervisor, Word Processing Department and Receptionist

1985 - 1991

FUTURE ELECTRONICS INC.

Executive Assistant to Vice President, World-wide Product Marketing

Executive Assistant to Vice President Distribution and Operations

Executive Secretary to Vice President Strategic Marketing

Secretary to Advertising and Marketing Manager

1982 - 1985

CANADIAN PACIFIC LTD

Production Assistant and Graphics Technician

1980 - 1982

TWINCRAFT LIMITED

Executive Assistant to President and Vice President

Computer Skills

Operating Systems: Windows 95 through 7

Applications Microsoft Office 2007 (Word, Excel, PowerPoint, Outlook)

Operating Systems: Office 2007

Certification

Support and Intervention in Palliative Care - John Abbott College (2012 – 2013)

Certified to perform end-of-life, whole person care, including providing patients and their families with physical, emotional and spiritual support.

Contact this candidate