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
This is an exciting opportunity to join HIV and Emerging Viruses
Regulatory Affairs where you will provide global regulatory strategic
and technical leadership of regulatory activities for pediatric
product development.
SPECIFIC EDUCATION & EXPERIENCE REQUIREMENTS:
* Extensive experience in Regulatory Affairs or other relevant
industry experience with BS/BA
* Significant level of experience in Regulatory Affairs or other
relevant industry experience with advanced degree
* Degree in a scientific field is preferred
* Pediatric drug development experience is required
SPECIFIC JOB RESPONSIBILITIES:
* Responsible for providing strategic regulatory guidance on the
development of global pediatric submissions, including those required
in the US and EU.
* Responsible for leading all pediatric-related regulatory
activities for assigned project(s) and territories in line with ICH
requirements, regional requirements and scientific and company
policies and procedures.
* Responsible for ensuring responsibilities of Applicant and/or
License Holder defined in legislation or regulatory guidance for
pediatric products is met for assigned product(s) and territories.
* Prepare and/or manage others? submissions that are technically
complex and require extensive interaction with departments outside of
Regulatory Affairs.
* Represents Regulatory at internal meetings and in conjunction with
the local regulatory liaison, at meetings with regulatory authorities.
* Maintains knowledge of highly complex regulatory requirements up
to date, contribute to preparation of new pediatric regulatory
guidance wherever possible, comments on draft regulatory guidance 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 have extensive knowledge of pediatric regulatory
requirements, including ICH requirements and regional requirements for
assigned territories and 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 developing and implementing regulatory strategy
and of managing complex negotiations with Regulatory Authorities.
* Excellent influencing and negotiation skills.
* Must be capable of taking a leadership role in updating and
preparing the Company for major changes in pediatric legislation in
assigned territories, which impact many departments.
* Must be capable of leading one or more teams in preparation of
submissions.
* 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.
Gilead Sciences, Inc. is a research-based biopharmaceutical company
founded in **Apply on the website**. Together we deliver life-saving
therapies to patients in need. With the commitment and drive you bring
to the workplace every day, you will be part of a team that is
changing the world and helping millions of people live healthier, more
fulfilling lives.
Our worldwide staff is a close community where you can see the
tangible results of your contributions, where every individual
matters, and everyone has a chance to enhance their skills through
ongoing development. Our scientific focus has resulted in marketed
products that are benefiting hundreds of thousands of people, a
pipeline of late-stage drug candidates, and unmatched patient access
programs to ensure medications are available to those who could
otherwise not afford them.
By joining Gilead, you will further our mission to address unmet
medical needs and improve life by advancing the care of patients with
life-threatening diseases.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and
affiliates (collectively "Gilead" or the "Company") to recruit select
and employ the most qualified persons available for positions
throughout the Company. ?Except if otherwise provided by applicable
law, all ?employment actions relating to issues such as compensation,
benefits, transfers, layoffs, returns from layoffs, company-sponsored
training, education assistance, social and recreational programs are
administered on a non-discriminatory basis (i.e. without regard to
protected characteristics or prohibited grounds, which may include an
individual?s gender, race, color, national origin, ancestry,
religion, creed, physical or mental disability, marital status, sexual
orientation, medical condition, veteran status, and age, unless such
protection is prohibited by federal, state, municipal, provincial,
local or other applicable laws). ?Gilead also prohibits
discrimination based on any other characteristics protected by
applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
_THIS EMPLOYER IS A CORPORATE MEMBER OF MYGWORK, THE BUSINESS
COMMUNITY FOR LGBTQ+ PROFESSIONALS, GRADUATES, INCLUSIVE EMPLOYERS &
ANYONE WHO BELIEVES IN WORKPLACE EQUALITY._
Position: Director, Regulatory Affairs (Paediatric GRL)
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
This is an exciting opportunity to join HIV and Emerging Viruses
Regulatory Affairs where you will provide global regulatory strategic
and technical leadership of regulatory activities for pediatric
product development.
SPECIFIC EDUCATION & EXPERIENCE REQUIREMENTS:
* Extensive experience in Regulatory Affairs or other relevant
industry experience with BS/BA
* Significant level of experience in Regulatory Affairs or other
relevant industry experience with advanced degree
* Degree in a scientific field is preferred
* Pediatric drug development experience is required
SPECIFIC JOB RESPONSIBILITIES:
* Responsible for providing strategic regulatory guidance on the
development of global pediatric submissions, including those required
in the US and EU.
* Responsible for leading all pediatric-related regulatory
activities for assigned project(s) and territories in line with ICH
requirements, regional requirements and scientific and company
policies and procedures.
* Responsible for ensuring responsibilities of Applicant and/or
License Holder defined in legislation or regulatory guidance for
pediatric products is met for assigned product(s) and territories.
* Prepare and/or manage others? submissions that are technically
complex and require extensive interaction with departments outside of
Regulatory Affairs.
* Represents Regulatory at internal meetings and in conjunction with
the local regulatory liaison, at meetings with regulatory authorities.
* Maintains knowledge of highly complex regulatory requirements up
to date, contribute to preparation of new pediatric regulatory
guidance wherever possible, comments on draft regulatory guidance 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 have extensive knowledge of pediatric regulatory
requirements, including ICH requirements and regional requirements for
assigned territories and 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 developing and implementing regulatory strategy
and of managing complex negotiations with Regulatory Authorities.
* Excellent influencing and negotiation skills.
* Must be capable of taking a leadership role in updating and
preparing the Company for major changes in pediatric legislation in
assigned territories, which impact many departments.
* Must be capable of leading one or more teams in preparation of
submissions.
* 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.
Gilead Sciences, Inc. is a research-based biopharmaceutical company
founded in **Apply on the website**. Together we deliver life-saving
therapies to patients in need. With the commitment and drive you bring
to the workplace every day, you will be part of a team that is
changing the world and helping millions of people live healthier, more
fulfilling lives.
Our worldwide staff is a close community where you can see the
tangible results of your contributions, where every individual
matters, and everyone has a chance to enhance their skills through
ongoing development. Our scientific focus has resulted in marketed
products that are benefiting hundreds of thousands of people, a
pipeline of late-stage drug candidates, and unmatched patient access
programs to ensure medications are available to those who could
otherwise not afford them.
By joining Gilead, you will further our mission to address unmet
medical needs and improve life by advancing the care of patients with
life-threatening diseases.
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and
affiliates (collectively "Gilead" or the "Company") to recruit select
and employ the most qualified persons available for positions
throughout the Company. ?Except if otherwise provided by applicable
law, all ?employment actions relating to issues such as compensation,
benefits, transfers, layoffs, returns from layoffs, company-sponsored
training, education assistance, social and recreational programs are
administered on a non-discriminatory basis (i.e. without regard to
protected characteristics or prohibited grounds, which may include an
individual?s gender, race, color, national origin, ancestry,
religion, creed, physical or mental disability, marital status, sexual
orientation, medical condition, veteran status, and age, unless such
protection is prohibited by federal, state, municipal, provincial,
local or other applicable laws). ?Gilead also prohibits
discrimination based on any other characteristics protected by
applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
_THIS EMPLOYER IS A CORPORATE MEMBER OF MYGWORK, THE BUSINESS
COMMUNITY FOR LGBTQ+ PROFESSIONALS, GRADUATES, INCLUSIVE EMPLOYERS &
ANYONE WHO BELIEVES IN WORKPLACE EQUALITY._
We need : English (Good)
Type: Permanent
Payment:
Category: Others
