Regulatory Affairs Clinical Trials Lead

Astrazeneca

2-5 years

Not Disclosed

Boston

10 July 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Clinical Trials Lead

Location: Mississauga, Ontario, Canada
Job ID: R-205367
Date Posted: 18/07/2024

At AstraZeneca, we foster a collaborative culture that promotes knowledge-sharing, innovative thinking, and ambitious projects. Our working model offers individualized flexibility, allowing employees to balance personal and professional commitments while maintaining a strong culture of collaboration by engaging face-to-face in our offices three days a week. Our head office and BlueSky Hub in downtown Toronto are designed to facilitate teamwork, brainstorming, and strategic planning.

We are committed to sustainability, recognizing that the health of people, the planet, and our business are interconnected. We are taking bold action to address major challenges like climate change, healthcare access, and disease prevention.

Role Introduction:

Join our Oncology Business Unit as a Regulatory Affairs Clinical Trials Lead. This key role involves preparing and implementing regional regulatory submission plans for allocated projects/products. You will oversee and lead the delivery of submissions, ensuring they meet regulatory standards. This position offers the chance to influence cancer treatment and patient outcomes significantly.

Key Responsibilities:

Regulatory Strategy and Tactics: Oversee regulatory strategies for clinical trial applications (CTAs) in Canada, including initial CTAs, amendments, and notifications, aligning with Health Canada and company requirements.
Risk Management: Identify and advise global teams on risks related to CTA approvability and execution, including investigational drug labeling.
Compliance Expertise: Maintain subject matter expertise in regulatory compliance and submissions.
Relationship Building: Develop positive relationships with internal customers and regulatory authorities to enhance regulatory outcomes.
Submission Process Management: Lead the submission review process and provide regulatory input to cross-functional and global teams.
Strategic Planning: Develop and implement regulatory strategic plans, including for novel trials with registration intent.
Regulatory Engagement: Prepare for and lead pre-CTA meetings with Health Canada and participate in advisory meetings.
Global Influence: Represent the Canadian market in global clinical trial and product development discussions.
Policy Advocacy: Comment on emerging Canadian regulations and policies.
Team Leadership: Lead and mentor team members to achieve regulatory outcomes related to CTAs.

Essential Skills/Experience:

Regulatory Expertise: In-depth knowledge of the Canadian regulatory environment and regulations, with 3-5 years of regulatory experience in the pharmaceutical or biotechnology industries.
Project Management: At least 2 years of regulatory project management experience.
Technical Proficiency: Proficient in MS Office.
Skills: Superior negotiation, problem-solving, and innovative thinking skills.
Communication: Strong written and verbal communication skills.
Risk Management: Ability to identify and mitigate risks.
Interpersonal Skills: Positive relationship-building abilities.

Desirable Skills/Experience:

Education: B.Sc. or equivalent in a related health science field; an advanced degree (M.Sc. or Ph.D.) is an asset.
Global Knowledge: Understanding of international regulatory activities and trends.
Company Knowledge: Familiarity with AstraZeneca's global and local policies and procedures.
Presentation Skills: Strong ability to present information clearly.

Summary:

Great People Want to Work with Us! Discover why we have been awarded the GTAA Top Employer Award for 10 years, the Top 100 Employers Award, and Canada's Most Admired Corporate Culture.

AstraZeneca is an equal-opportunity employer committed to diversity and inclusion. We provide a workplace free from discrimination and are dedicated to accommodating persons with disabilities throughout the recruitment process. Requests for accommodation can be made by emailing AZCHumanResources@astrazeneca.com.

Join us in our mission to make a difference. Apply today!

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Regulatory Affairs Clinical Trials Lead

Job Description

Job Title: Regulatory Affairs Clinical Trials Lead

Role Introduction:

Key Responsibilities:

Essential Skills/Experience:

Desirable Skills/Experience:

Summary:

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