Director, Regulatory Affairs

Local Jobs Gilead Sciences in Business Development
  • United States, Foster City, CA 94404 View on Map
  • Post Date : August 4, 2020
  • Apply Before : September 3, 2020
  • Share:

Job Description

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Director, Regulatory Affairs

Specific Job Responsibilities:

  • Serves as a Core member of the cross-functional Project Team representing the global regulatory strategy for assigned projects
  • Leads Regulatory Project Team for assigned projects
  • Leads cross-functional/cross-regional Regulatory Submission Teams
  • Participates on other Subteams
  • Oversees contacts for local Regulatory Authorities
  • Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
  • Oversees submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs (e.g. supplements, annual reports, responses to request for information, original INDs/CTAs and NDAs/MAAs for assigned territories)
  • Responsible for development, oversight and communication of global and regional (as applicable) regulatory strategy for assigned projects and regions
  • Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation and regulatory guidance is met for assigned product(s) and territories
  • Oversees preparation and maintenance of country specific labeling and product packaging (region specific) and ensuring alignment with relevant global Regulatory strategy
  • 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 information to project teams and senior management
  • Initiates or contributes to local and/or global process improvements which have a significant impact on the business
  • Excellent verbal, written, negotiation and interpersonal communication skills are required
  • Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities
  • Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories and have an understanding of current global and regional trends in Regulatory Affairs and ability to assess the impact of these requirements to the business
  • Must be capable of taking a leadership role in updating and preparing the Company for major changes in legislation in assigned territories, which impact many departments
  • Prepare and/or manage others’ submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs
  • Must be capable of leading one or more teams in preparation of submissions and maintenance of licenses.
  • Work is performed under consultative direction towards corporate regulatory goals and objectives
  • Schedules and arranges own activities and those of direct report(s) (if applicable)
  • Is recognized as an expert resource for Regulatory Advice in other departments
  • Previous people management experience is required

Education and Experience:

  • 12+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
  • 10+ years of experience in Regulatory Affairs or other relevant industry experience with advanced degree
  • Degree in a scientific field 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 [email protected] 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:

Please log onto your Internal Career Site to apply for this job.

Other jobs you may like

Director, Regulatory Affairs

Local Jobs Regeneron in Business Development
  • United States, Tarrytown, NY View on Map
  • Post Date : July 9, 2020
  • Apply Before : August 8, 2020
  • Share:

Job Description

Position Summary

SUMMARY:
The Director of Regulatory Affairs will provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for Regeneron’s clinical asset candidates.

JOB DUTIES:

  • This position in Regulatory Affairs involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of Regeneron’s quality, preclinical and clinical drug development programs, policies and procedures, so that Development teams can meet all objectives within specified timelines and so that the necessary

state of compliance is maintained relative to all regulatory commitments/requirements.

  • Develop regulatory strategies for assigned programs in collaboration with Regeneron’s Regulatory senior management and by analysis of guidance’s and assessment of drug developed for similar indication to obtain approval of activities in support of Regeneron’s development and marketing objectives within specified timelines

  • Liaison responsible for communication with FDA and other health authorities for assigned programs

  • Manage/lead regulatory activities associated with Regeneron assigned drug development programs.

  • Management of the planning, preparation and submission of licensing applications (BLA/MAA).

  • Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs. Provide training on applicable requirements for scientific staff as required.

  • Manage and mentor direct reports and/or junior staff members.

JOB REQUIREMENTS:

  • Ph.D., PharmD, or MD required

  • A minimum of 10 years of pharmaceutical industry experience, at least 5 of which should include regulatory experience.

  • Must possess excellent written and verbal communication skills

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Other jobs you may like

Go to Top