As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!
location: South San Francisco, California
job type: Contract
salary: $65.00 - 79.61 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
The company's West Coast Hub located in South San Francisco, CA is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
We are seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the GRL as needed. You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams. You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations. Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed.
- You must exhibit excellent operational competences, including planning, organizing and other project management skills.
- You demonstrate solid oral and written communication skills.
- You can independently build networks with cross-functional team members to support collaboration and generate innovative solutions by identifying novel approaches to address work challenges and opportunities.
- You have knowledge and understanding of applicable regulations, including experience in interpretation of regulations, guidelines, and policy statements.
qualifications:
- Combination of the following can be considered: PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs; MS with 4+ years; BS with 5+ years
- Knowledge and understanding of applicable regulations and experience in interpretation of regulations, guidelines, and policy statements
- Excellent operational skills including planning, organizing and ability to represent the department in project teams
- Ability to work independently with minimal direction and to work well within cross-functional teams
- Solid oral communication and writing skills
- Develops collaborative relationships to facilitate the accomplishment of work goals
- Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
- Can build networks to obtain cooperation without relying on authority
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
