Contract Regulatory Affairs Manager

Do you want to be part of an inclusive team that works to develop innovative therapies
for patients? Every day, we are driven to develop and deliver innovative and effective
new medicines to patients and physicians. If you want to be part of this exciting work,
you belong at Astellas

Astellas Pharma Canada, Inc. is committed to providing patients, customers, community,
and employees with a bright future by changing tomorrow. This commitment is made
possible because we are a different kind of pharmaceutical company. Headquartered in
Markham, Ontario, Astellas Pharma Canada, Inc. has been named on the list of Best
Workplaces in Canada by the Great Place to Work® Institute for the seventh
consecutive year in a row. For more information on Astellas, please visit our website at

Astellas Pharma Canada is currently searching for a Contract Regulatory Affairs Manager
reporting to the Regulatory Affairs Sub-Regional Lead & Affiliate Regulatory Affairs Lead
Canada. This is a one year contract position located in our head office in Markham, Ontario.

**Description**

The contract Regulatory Affairs Manager is responsible for the following:
Independently providing overall regulatory directions for assigned projects including
writing, preparing and/or directing preparation New Drug Submission, Supplements and
CTAs as well as identifying and resolving issues with Health Canada and other Astellas
affiliates relating to all regulatory issues.***

Interactions with Health Canada submission reviewers and completing responses to
Health Canada review questions within specified guidelines and timelines.

Influencing and negotiating regulatory requirements internally with global and cross
functional teams and with Health Canada.

Providing guidance and training of colleagues.***

**Essential Job Duties**

Develops and implements the overall regulatory strategies for submissions for
assigned projects.

Independently writes and directs preparation of all components for Health Canada

submissions such as CTAs, NDSs and Supplements involving the
preclinical/clinical/CMC aspects to meet all requirements outlined in Health
Canada’s Guidelines and Policies. Included among this function is supporting the
authoring of necessary labels, summary tables of data from research and
manufacturing reports.

Independently determines the best ways to present information within regulatory
submissions to optimize the reviewability by Health Canada. Ensures that the
compilation and transmittal of submissions are within defined time schedules and
meet Health Canada, Astellas global RA and APCA established standards/SOPs.

Independently prepares responses to questions from Health Canada screeners

and reviewers in consultation with local and global project teams within Health
Canada’s specified timelines. Identify and resolves issues for responses.

Influences and negotiates regulatory requirements with Health Canada and

Astellas for assigned projects.

Participates as a member of certain project teams/task forces (including those
coordinated through global project teams) requiring the interpretation of Health
Canada regulations/guidelines on areas pertaining to submissions.

Actively seeks out knowledge of overall corporate strategy and other general

factors that affect the regulatory positions taken within the company and with
Health Canada and utilizes this knowledge in the performance of the job.

Continues to develop increased understanding of the responsibilities of the
regulatory affairs department by assisting other in tasks not a direct responsibility
of this position and by attending training courses in the area of regulatory affairs.

Works closely with other individuals/groups in regulatory affairs (both inside

Astellas and external) to achieve departmental consistency. Provides guidance
and assists in training to other regulatory staff.

Interacts with regional and global regulatory staff to exchange information and

ensure that information submitted to Canada is consistent with that submitted in
other countries.

Accountable for maintaining a thorough understanding and adherence to all
applicable code, policies and regulations (i.e. Innovation Medicines Canada
Code of Ethical Practices, code of conduct, etc.). Upholds a commitment to
compliance and operates with integrity within all business activities. Upholds a
commitment to compliance by exercising proper supervision and oversight to
ensure due diligence within one’s region.

**Required Qualifications
Bachelor of Science degree in life sciences. Master of Science preferred. Scientific
knowledge to regulatory issues.

Regulatory affairs experience from Five (5) or more years; excellent understanding

of TPD regulations and guidelines.

Exposure to health science research and/or pharmaceutical industry
manufacturing/development gained through Five (5) or more years of industry
experience.

Excellent writing skills with the ability to meet regulatory requirements and

standar