Senior Manager, Regulatory Affairs

Chez Eisai, la mission de soins de santé humaine (hhc) d'Eisai est de satisfaire les besoins médicaux non satisfaits et d'augmenter les avantages que les soins de santé apportent aux patients, à leurs familles et aux soignants. Nous sommes une société pharmaceutique en pleine croissance qui fait une percée dans les domaines de la neurologie et de l'oncologie, avec un fort accent sur la recherche et le développement. Notre histoire comprend le développement de nombreux médicaments innovants, notamment la découverte du traitement le plus utilisé au monde contre la maladie d'Alzheimer. Alors que nous poursuivons notre expansion, nous recherchons des personnes très motivées qui souhaitent travailler dans un environnement en évolution rapide et faire la différence. Si tel est votre profil, nous voulons avoir de vos nouvelles.

Job Description

We are searching for a high performing, over-achieving, patient-centric regulatory expert for our Senior Manager, Regulatory Affairs position.  Eisai is a company that focuses not only on developing pharmaceuticals but also the potential of corporative activities that go beyond the provision of medicines. We believe that our mission is not limited to simply delivering the drugs to the patient but giving first thought to patients and their families.

Purpose

The Senior Manager, Regulatory Affairs is responsible for managing and leading the regulatory activities to obtain and maintain drug product registration status in compliance with Canadian drug laws and regulations, as well as Eisai policies and procedures. As a subject matter expert and leader for Regulatory Affairs, the individual will provide guidance to local and global business partners.

Key Accountabilities/Responsibilities:

• Develop and implement regulatory strategic plans for product registrations and lifecycle management.

• Lead the preparation of regulatory submissions including Pre-submission activities, New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs), and ad hoc reports to Health Canada, and maintain the life cycle of currently marketed products.

• Lead the development and review of responses to Health Canada queries in relation to clinical efficacy and safety, clinical pharmacology, biopharmaceutics and preclinical subject matter (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]).

• Lead interactions with Health Canada throughout the submission review cycle to ensure timely regulatory approval and optimal labelling.

• Collaborate with global cross-functional teams and the Global Regulatory Affairs (GRA) function/teams to facilitate regulatory activities.

• Collaborate with internal partners to ensure alignment of regulatory affairs strategy with business priorities, and to meet strategic business objectives and stretch goals.

• Develop effective working relationships with business partners and the authorities to support regulatory strategies.

• Manage emerging issues (e.g. new safety finding) and the associated risk communications.

• Provide regulatory guidance and input to internal partners on messaging, promotional material review, and PAAB responses.

• Monitor the regulatory and competitive environments, interpreting changes, analyzing gaps and conducting impact assessment, and participating/leading implementation into systems/processes.

• Actively contribute to the improvement of departmental processes and initiatives to enhance the internal work environment.

• Mentor Associates and Interns as applicable.

Qualifications/ Requirements

• B.Sc. in life science or relevant scientific field.

• Minimum 8-10 years of experience in Canadian brand name pharmaceutical Regulatory Affairs.

• Experience in the neurology and/or oncology therapy areas would be an asset.

• Knowledge of Canadian drug laws, the Canadian Food and Drug Regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions.

• Ability to interpret and understand Regulations in the context of the scientific and commercial environment.

• Demonstrate ability to develop effective regulatory strategies aligned with global and local commercial objectives.

• Experience with the preparation and approval of regulatory submissions for brand name prescription drugs to Health Canada.

• Must have experience in clinical and therapeutic aspects of submissions.

• Strong working knowledge of the drug development process and commercialization process.

• Highly innovative (strategic and functional) and creative problem solver and decision maker who can apply continuous improvement techniques to gain efficiencies in submission preparation, product approval process, and resolving issues.

• Excellent oral and written communication skills including the ability to present information and contribute ideas in small and large groups.

• Strong problem solving and analytical skills.

• Good influencing and relationship management skills.

• Excellent negotiation skills.

• Fully developed project management skills.

• Agile and able to effectively navigate change.

• Must act with integrity and demonstrate a strong and effective risk management perspective

• Ability to provide and receive feedback, raise issues, share experiences and lessons learned.

• Proactive and seeks to constantly learn and develop, ensures that skills meet changing business needs.

• Foster strong team collaboration, with the ability to engage constructively with others and demonstrate a positive mindset. Open to diverse ideas, styles and perspectives.

• Strong commitment to quality of submissions mindset.

• Strong computer literacy and computer skills including Word, Excel, PowerPoint, Outlook, OneDrive and OneNote.

Preferred Qualifications
 

Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

Déclaration de politique d'égalité des chances en matière d'emploi
Eisai s'engage dans une politique d'égalité des chances en matière d'emploi pour tous les employés et candidats. La Société prône également un environnement de travail sans discrimination, harcèlement, ni représailles. Il est de la politique d'Eisai de respecter toutes les lois et réglementations provinciales applicables concernant la non-discrimination en matière d'emploi et de ne pas discriminer contre un employé ou un candidat à l'emploi sur la base d'une caractéristique protégée, telle qu'établie par la loi en vigueur, y compris, entre autres, la race, la nationalité ou l'origine ethnique, la couleur, la religion, l'âge, le sexe, l'orientation sexuelle, l'identité ou l'expression du genre, l'état civil, la situation familiale, l'invalidité ou les caractéristiques génétiques.