Sr Manager, Regulatory Project Management

Location
Foster City, CA, United States
Posted
Apr 23, 2021
Ref
2232225
Required Education
Bachelors Degree
Position Type
Full time
Sr Manager, Regulatory Project Management
United States - California - Foster City

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. Gilead's 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 company's five core values. That's 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

Specific Responsibilities and skills for Position:

The Senior Manager in Regulatory Project Management will be responsible for the coordination, prioritization and tracking of regulatory activities and submissions associated with the company's research, development and post-marketing activities for a variety of therapeutic areas. Regulatory activities may include support for both products in early and late stage development and marketed products.

Essential Duties and Job Functions:

The Senior Manager in Regulatory Project Management will develop and maintain detailed timelines for global regulatory activities and submissions for assigned therapeutic areas and ensure planning and coordination of activities via the Regulatory Submission Team.

This role will foster effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate, via proactive networking and facilitation of the Regulatory Project Team.

This incumbent is responsible for:
  • ensuring regulatory submissions are prepared according to defined Corporate or Regulatory timelines
  • working with Regulatory Regional leads to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
  • tracking regulatory commitments and timelines for maintenance activities such as Post marketing Commitments and Follow-up Measures, and ensuring appropriate submissions are made in accordance with applicable requirements and deadlines.
  • Strategic oversight of one or more therapeutic areas
  • Managing at least one direct report, as appropriate


The Senior Manager in Regulatory Project Management will initiate or contribute to local and global process improvements within the Regulatory Affairs department and cross-functionally, which will have a significant impact on the business Will also work collaboratively with other functional areas and Regulatory Affairs' functions at other sites.

Knowledge, Experience and Skills:
  • Excellent verbal, written, negotiation and interpersonal communication skills are required. Excellent organizational skills and ability to work on a number of projects with tight timelines is required.
  • Will ideally have a modest knowledge of regulatory requirements specific to key regions such as the US and EU, and have a general awareness of current global and regional trends in Regulatory Affairs.
  • 8+ years of relevant experience is required; experience in both Regulatory Affairs and Project Management is sought, and a BA degree in a relevant discipline. An advanced degree and/or PMP certification is preferred.
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.
For Current Gilead Employees and Contractors:
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