Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
As a Senior Manager, CMC Regulatory Affairs for Biologics, at Gilead you will be responsible for the regulatory strategy for one or more molecules in the Biologics portfolio. This position will ensure “right first time” global approvals of CMC regulatory (Biologics) submissions, and “right to operate” by maintaining the global clinical or commercial submissions. In addition, you will be accountable for implementation of CMC regulatory guidelines, regulations and current environment to assure global approvability.
JOB DESCRIPTION
- CMC regulatory lead for a single or multiple products.
- Responsible for preparing and submitting complex regulatory documents which require interaction with departments outside of CMC Regulatory Affairs for investigational and commercial products, in line with ICH requirements, regional requirements, and scientific and company policies and procedures. Examples include safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories.
- Contribute to the development of regulatory strategies and solutions for CMC challenges for clinical or commercial projects.
- Responsible for interpretation and implementation of ICH and other global guidelines with a goal of an approved/ harmonized regulatory control strategy.
- Partner across CMC Regulatory Affairs, PDM, and other functional groups across Gilead.
- Demonstrate and model Gilead’s Core Values, Leadership Commitments, and People Leader Accountabilities; Embrace and comply with global CMC principles of integrity.
QUALIFICATIONS
- Undergraduate or advanced degree in life sciences or related field with significant CMC, manufacturing, research, development, regulatory or related work experience in the biopharma or related industry with at least 8 years of experience with a BA/BS, or 6 years with an MA/MS/MBA, or 2 years with a PhD or PharmD.
- Significant experience supporting development and submissions management of regulatory filings in the life sciences industry, including experience and proven effectiveness independently completing routine regulatory submissions.
- In-depth knowledge of global CMC regulatory landscape.
- Capable of developing and implementing regulatory strategy and leading small teams in execution of strategy.
- Excellent collaboration and organizational skills and ability to work on and/or oversee a number of projects with tight timelines.
- Excellent verbal, written communication, and presentation 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.
