Manager, Regulatory Affairs CMC (Biologics - Large Molecule))
Manager, Regulatory Affairs CMC (Biologics - Large Molecule))
United States - New Jersey - Morris Plains
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Manager, Regulatory Affairs, CMC - Biologics - LArge Molecule
Specific Job Responsibilities
- The Manager Regulatory Affairs CMC will provide key Regulatory CMC support for primarily biologic investigational drugs being evaluated for the treatment of oncology, HIV and liver diseases.
- The Manager, working with the project team and regional regulatory leads in the US, EU and other countries, will support the development of global regulatory strategies, provide regulatory guidance, and critically review documents for submission to regulatory authorities.
- May serve as Regional Lead on cross-functional/ cross-regional Regulatory Submission Teams.
- May participate on other Subteams, as applicable.
Essential Job Functions:
- Responsible for preparing and submitting complex regulatory documents which require interaction with departments outside of Regulatory Affairs CMC for investigational and commercial biologics products, in line with ICH requirements, regional requirements and scientific and company policies and procedures. Examples include original INDs and BLAs, amendments, supplements, annual reports and license renewals.
- May provide strategic Regulatory CMC advice as appropriate.
- Provides input to senior Regulatory Affairs CMC professionals in the preparation of country specific labeling and for ensuring product packaging and associated information is updated and maintained in accordance with the product license as applicable.
- Maintains knowledge of regulatory requirements and communicates changes in regulatory information to Regulatory project teams in a timely manner.
- Work cooperatively with regional regulatory sites to support the accurate and timely communication of critical information. Provide support for cGMP activities as they relate to regulatory affairs.
- Work is performed cross-functionally within a matrixed organization. under limited direction of a senior Regulatory Affairs CMC professional and line manager.
Knowledge & Skills:
- Excellent organizational skills and the ability to work on a number of projects with tight timelines.
- Excellent verbal and written communication skills and interpersonal skills.
Must work well under demanding deadlines and have excellent attention to detail.
- Knowledgeable of regulatory requirements, including ICH requirements and US regional requirements
Required Education & Experience
- A Bachelor's Degree and a minimum of seven (7) years of relevant industry experience in Regulatory Affairs CMC or other relevant industry experience, OR a Master's Degree and a minimum of five (5) years of experience in Regulatory Affairs CMC or relevant industry experience.
- Experience with BLA submissions
- Experience in Regulatory Affairs CMC for biologics.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
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