Sr. Associate, Regulatory Affairs

Job Summary:

The Sr. Associate, Regulatory Affairs will have the primary responsibility of preparing and filing new products for regulatory approval of the products for Hikma Canada. This individual will work as a project leader with individuals across all departments of the company, business partners, and affiliate sites. The Sr. Associate, Regulatory Affairs will support the Quality and Regulatory departments in the activities of submissions (Health Canada and formulary), communication with regulatory agencies, labelling, compliance, including Change Control and post-market submission and vigilance activities for the Canadian site.

 

Reporting Relationships:

Core Relationships
    Quality Assurance and Regulatory Departments
    Intercompany Affiliates Departments
    Contract Third Party Business Partners
    Other company divisions as needed and required by the position

 

Responsibilities & Duties:

 

Key Responsibility: Regulatory Affairs (85%)

The key responsibilities and duties for which the Sr. Associate, Regulatory Affairs will be responsible include, but are not limited to:

•    Assist in prepare of pre- and post-market product dossiers for drugs for submission to Health Canada.
•    Review, analyze, interpret, and provide guidance on relevant technical documents from development sites and provide regulatory guidance to internal and external partners.
•    Liaison with manufacturing for labelling dielines, commercial and marketing for the development of trade dress for product labelling and coordinate the generation of labels with graphic designer.
•    Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies for verification of compliance.
•    Coordinate the preparation of formulary submissions and listings as required.
•    Ensure post approval regulatory compliance of marketed drug products meet company and regulatory requirements.
•    Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

•    Monitor Health Canada’s Product Monograph Brand Safety Updates and update Product Monographs as necessary within stipulated regulatory timelines.
•    Maintain and update Certified Product Information Document for marketed products.
•    Assist in the coordination of submissions for Exceptional Importation products.
•    Assist in due diligence activities as required.

 

Key Responsibility: Quality Assurance Support (15%)
•    Support the efficient and timely release of products to the marketplace and establish and maintain quality standards and related policies for all finished products.
•    Support to establish and enforce Good Manufacturing and Quality Control Procedures.
•    Liaise with internal and external partners to ensure compliance with product approvals, regulatory requirements, and GMPs.
•    Assist in the development and implementation of Quality Assurance programs and projects including the management of SOPs, change controls, document management and investigations, and annual product reviews.
 

Qualifications:

o    B.Sc. in chemistry, pharmacy, or another life science. 
o    3-5+ years’ experience as a Regulatory Affairs Professional. Experience with parenteral products required.
o    Demonstrated knowledge of TPD, Health Canada, FDA and ICH guidelines, GMPs, regulations and other relevant policies. 
o    Strong communication skills (written and verbal). 
o    Ability to multi-task, remain flexible, manage priorities, and adhere to deadlines.
o    Results oriented with a proven ability to prioritize work and meet challenging deadlines.
o    Proficiency in MS Office, Sharepoint, Outlook and eCTD software.
o    Strong written and verbal communication skills
o    Excellent organization, time management, and prioritization skills
o    Meticulous and detail-oriented with strong work ethic
o    Sound problem solving and decision-making abilities
o    Works independently and accomplishes tasks without supervision
 

This description outlines the principal functions of the job identified and should not be considered a detailed description of all requirements that may be inherent in the job.