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(this posting is closed/inactive)
Director, Regulatory Affairs
Burnaby, BC CANADA, WA 00000 United States
Health and dental benefits
Tekmira is a clinical and preclinical development stage biotechnology company with a prominent position in siRNA based drugs. A leader in developing effective molecular therapeutics treating a wide range of diseases, including cancer, metabolic disorders and infectious disease, Tekmira employs its proven nucleic acid delivery platform to deliver siRNA, systemically, to disease sites. The impact of our research is reflected by our strong publication record in high ranking peer-reviewed journals.
The Director Regulatory Affairs will report to the Chief Medical Officer (CMO), and will be responsible for directing and implementing regulatory affairs strategy and practices.
Duties and responsibilities will include:
• Provides strategic direction, oversight and management of Regulatory Affairs function aligning department and project objectives with overall corporate objectives and tailoring them to the appropriate needs of Tekmira and its partners.
• Assumes a lead role in directing Tekmira’s regulatory approval strategy for all products ensuring internal alignment on direction and activities. Directs and develops internal staff in a collaborative manner to achieve goals.
• Responsible for all regulatory submissions and documentation including the preparation, submission and presentation of various regulatory documents, including INDs, DMFs, PLA/BLAs, NDAs and European dossiers.
• Works with various internal and external groups to coordinate documents needed for regulatory submissions and takes a hands on approach to compiling these submissions.
• Responsible for communications and interactions with regulatory authorities.
• Collaborates, where necessary, with a variety of internal and external technical and medical experts to provide input into and support to Tekmira’s drug research and development pipeline pipeline.
• Maintains up to date knowledge of current regulatory requirements in various jurisdictions.
• Maintains up to date knowledge of company philosophies, plans and processes pertaining to finance planning and reporting, human resources planning, and project planning, management and reporting.
• Other duties and responsibilities as may be assigned.
Education, training, experience:
• MS in a related Life Sciences discipline and a minimum of 10 years of directly related biotechnology or pharmaceutical experience.
• A minimum 5 years experience leading a Regulatory Affairs function in a similar role.
• Experience with novel therapies; DNA and/or RNA related experience an asset.
• Experience with the preparation, submission and presentation of various regulatory documents, including INDs, DMFs, PLA/BLAs, NDAs and European dossiers.
• Strong communication skills and demonstrated ability to build relationships and act as liaison with regulatory agencies and partners on various matters.
• Developmental experience with quality programs, including document control, training and auditing programs.
• Strong analytical, verbal and written communication skills and sound understanding of the drug development process.
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