Regulatory Affairs Associate

**Contract - Regulatory Affairs Associate
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 Associate in
our Regulatory Affairs Department reporting to the Director, Regulatory Affairs, Quality
Assurance and Pharmacovigilance. This is a head office one year contract position located in
the Markham, Ontario area.

**Description**:
The Regulatory Affairs Associate is responsible to support a significant component of text
preparation and/or selection and edit of electronic or hard copy text modules for New Drug
Submissions (NDSs), Supplemental NDSs (SNDSs), Clinical Trial and Applications (CTAs)
involving clinical/preclinical and chemistry and manufacturing control (CMC) aspects of
submissions. With guidance responsible for multiple regulatory liaison functions with Health
Canada and other Astellas affiliates relating to CTAs and other submissions, interacting with
Health Canada submission screeners/reviewers under the supervision of senior Regulatory
Affairs (RA) staff. Supporting the preparation of complete responses to Health Canada review
questions within Health Canada
- specified guidelines.

**Essential Job Duties**:
Support Regulatory filings and review/approval process for products in portfolio,
such as CTA’s, NCs, SNDS, NDSs involving the preclinical/clinical/CMC aspects
to meet all Health Canada requirements outlined in Health Canada Guidelines
and Policies as well as current Health Canada and ICH requirements for
electronic submissions (support electronic submission component). Support
/prepare complete responses to questions from Health Canada submission
reviewers and screeners within Health Canada-specified guidelines under the
general direction of the supervisor. Ensures that the compilation and transmittal
of submissions are within defined time schedules and meet Health Canada and
Astellas established standards/SOPs.

Identifies and proposes solutions to issues within own areas of expertise.
Identifies and seeks guidance to facilitate resolution of issues outside areas of
expertise.

With guidance from senior RA staff negotiates regulatory requirements with
Health Canada (minor issues only) and Astellas under the general direction of
RA staff.

Collaborate with project teams/task forces (e.g., APCA/global teams) requiring
the interpretation of Health Canada regulations/guidelines on areas pertaining to
CTAs/NDSs/Supplements with alignment to core objectives.

Seeks out knowledge of the overall product specific strategy and other general
factors that affect the regulatory positions and utilizes this knowledge in the
performance of the job.

Works closely with other individuals/groups in Regulatory Affairs (both inside
Astellas and external) to achieve departmental consistency.

Support cross-functional teams with applicable pre
- and post-marketing activities.

Interacts with international regulatory staff to exchange information and ensure
that information submitted to Canada is consistent with that submitted to other
countries.

Performs other duties as assigned. Supports the regulatory operational function
as required.

Identifies and reports adverse events and product complaints as per Corporate
and Regulatory standard procedure

**Required Qualifications**:
Education, Experience, Skills and other Requirements

University degree in Science, required. Master of Science degree in life sciences,
preferred. Post-graduate Certificate in Regulatory Affairs, preferred.

Some Regulatory affairs experience (minimum 6 months) ; excellent understanding of
Health Canada regulations and guidelines.

Exposure to health science research and/or pharmaceutical industry manufacturing and/or
development gained industry experience.

knowledge to regulatory issues.

Excellent writing skills with the ability to meet regulatory requirements and standards
required. Ability to communicate effectively and maintain effective relationships required**.**
Oral presentation skills for internal and external purposes.

Proficient in Microsoft Office. Computer skills compatible with current electronic

submission requirements and ability to implement future requirements.

**Preferred Qualifications**:
Bilingual (French an