Assoc Director, Regulatory Affairs CMC

Gilead Sciences; Edmonton; On-site; CAD 120,000 - 150,000; Full time

Job summary

A major biopharmaceutical company in Canada is seeking a Director for CMC Regulatory Affairs. This role involves leading regulatory activities and strategies for drug development. The ideal candidate has at least 10 years of experience in CMC Regulatory Affairs and a Bachelor’s degree in a scientific discipline. Excellent communication and organizational skills are essential. This position offers a full-time employment opportunity in a dynamic environment.

Qualifications

• 10 years of experience in CMC Regulatory Affairs or relevant industry experience (8 with advanced degree).
• Proven track record of developing and leading global CMC regulatory strategies and submissions.
• Deep understanding of global regulatory requirements and guidelines.

Responsibilities

• Lead all CMC regulatory activities and strategy development for assigned project(s).
• Collaborate with internal teams to identify and rank risks and propose mitigation plans.
• Ensure up-to-date knowledge of complex regulatory requirements.

Skills

Proofreading

Adobe Acrobat

FDA Regulations

Manufacturing & Controls

Biotechnology

Clinical Trials

Research & Development

GLP

cGMP

Product Development

Chemistry

Writing Skills

Education

Bachelor's degree in a relevant scientific discipline

Advanced degree preferred

Job description

Overview

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

Gileads mission is to discover develop and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

Responsibilities

Responsible for leading all CMC regulatory activities and strategy development for assigned project(s) in line with ICH requirements regional requirements scientific knowledge and company policies and procedures.

Actively collaborates with internal teams (including Technical Development Manufacturing Supply Chain and Quality) to identify and rank risks propose risk mitigation plans and develop / execute robust CMC regulatory strategies.

Leads CMC regulatory project teams and serves as core member of cross-functional PDM strategy teams.

Ensures up-to-date knowledge of highly complex regulatory requirements contributes to preparation of new regulatory guidances comments on draft regulatory guidances and communicates changes in regulatory CMC information to project teams and senior management.

Provides advice and drives decisions on regulatory issues for which there may not be clear / specific regulatory guidance.

Collaborates with colleagues across the global CMC RA organization Gilead Regulatory Affairs and affiliates on internal meetings and leads global Health Authority interactions for CMC related topics.

Initiates or contributes to local and / or global process improvements which have a significant impact on the business.

Provides regulatory impact assessments for changes managed in the Gilead quality systems and participates in technical risk assessment exercises.

Coaches and mentors junior regulatory CMC RA staff.

Contributes to update maintain and verify documents submissions and registrational details in a validated Regulatory Information Management system.

Specific Education & Experience Requirements

10 years of experience in CMC Regulatory Affairs (CMC RA) or other relevant industry experience (8 with advanced degree). Requires a bachelors degree in a relevant scientific discipline. An advanced degree is preferred.

A proven track record of developing and leading global CMC regulatory strategies and submissions (IND IMPD / CTA NDA MAA etc) in all phases of drug development including life cycle management.

Deep understanding of global regulatory requirements and guidelines.

Collaborative proactive and highly organized approach to work. Ability to prioritize and manage multiple projects simultaneously in a dynamic company environment. Excellent verbal and written communication negotiation and interpersonal skills.

People Leader Accountabilities

Create Inclusion - knowing the business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.

Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow develop and realize their purpose.

Empower Teams - connect the team to the organization by aligning goals purpose and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

For Current Gilead Employees and Contractors

Please apply via the Internal Career Opportunities portal in Workday.

Required Experience

Director

Key Skills

Proofreading, Adobe Acrobat, FDA Regulations, Manufacturing & Controls, Biotechnology, Clinical Trials, Research & Development, GLP, cGMP, Product Development, Chemistry, Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1