Join a mission-driven team at the forefront of rare disease therapeutics. As a Sr. Regulatory Affairs Manager, you will serve as a key liaison between program teams and global health authorities to drive critical advances in our clinical-stage pipeline. This role is central to accelerating therapeutic innovation and bringing life-changing treatments to patients with high unmet medical needs.
The Global Regulatory Affairs (GRA) department acts as the essential interface between product development teams and global Health Authorities (HAs). GRA's primary responsibility is to obtain and maintain product approvals throughout the entire lifecycle and anticipate and interpret current regulatory legislation, guidelines, and intelligence to guide internal teams.
The specialized Regulatory Affairs Nonclinical / Clinical team defines the regulatory strategy and pathway by:
- Leading the development and execution of the nonclinical/clinical regulatory strategy in alignment with the overall clinical development plan.
- Preparing relevant sections of regulatory filings required for product approvals.
- Coordinating and leading engagements with Health Authorities before, during, and after regulatory milestones.
The Regulatory Affairs Nonclinical / Clinical Senior Manager is a key subject matter expert who:
- Leads, conceives, and executes the global clinical and nonclinical regulatory strategies across a program's lifecycle.
- Acts as the key liaison with Health Authorities.
- Leads the preparation of all Nonclinical / Clinical documentation for global regulatory filings, including post-approval activities and expansion opportunities.
- Collaborates, influences, and negotiates with senior nonclinical and clinical leaders to shape product strategies, leveraging advanced regulatory knowledge.
location: San Rafael, California
job type: Contract
salary: $69.81 - 82.13 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
Regulatory Strategy Development
- Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Clinical Development Plan (CDP) and nonclinical development plan with input from clinical and nonclinical Subject Matter Experts (SMEs), respectively, and regional regulatory leads.
- Provide strategic insight to the GRT regarding product development, and serve as Regulatory contributor to partner teams (e.g., study execution teams, clinical development team etc.) as appropriate
- In collaboration with regional regulatory representatives, ensure that feedback from global Health Authorities is incorporated into the global nonclinical and clinical development strategy.
- Incorporate RA INTL guidance on development programs (i.e., INTL requirements or policies that may impact clinical development and commercialization).
- Develop global pediatric strategy; collaborate with regional leads on the content for regional pediatric plans (e.g., PIP); ensure global pediatric strategy is reflected in the Global Regulatory Plan; ensure any changes to CDP or Nonclinical development plans are assessed by regional leads for impact to pediatric plan agreements with Health Authorities.
- Lead/support strategy for life-cycle expansion opportunities
- Act as a key contributor to the Clinical and Nonclinical Development Plans and ensure that they incorporate consideration of current global health authority precedents and regulatory guidance.
- Provide both proactive and reactive strategic input and regulatory expertise in the design and conduct of clinical and nonclinical studies
- Contribute critically to the scientific interpretation and integration of clinical and nonclinical study results.
- Review and provide comments on all company- sponsored abstracts, manuscripts and publications of original research and press-releases, as requested.
- In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studies.
- Lead planning and preparation of the clinical and nonclinical strategy and content for global HA meetings, working closely with SMEs and regional regulatory leads. Deliverables include core content for the briefing book, presentation, and the Q&A strategy map.
- Lead clinical and nonclinical FDA interactions in alignment with corporate and/or program goals.
- Serve as the point of contact for FDA regarding nonclinical/clinical communications.
- Ensure that global HA feedback is incorporated into the clinical and nonclinical aspects of the development programs.
- Broadly, ensure that the clinical and nonclinical content is adequately presented in submissions leading to successful clinical trial applications and product approvals.
- Oversee any CRO/vendors that are contracted to perform any of the regulatory activities related regulatory submissions and HA interactions
- IND/CTAs:
- Lead planning and preparation of core clinical and nonclinical content for global clinical trial applications, collaborating with SMEs and regional regulatory representatives.
- Lead collaboration with CROs to support global clinical trials in line with corporate goals.
- Coordinate maintenance of IND/CTAs globally through clinical trial completion.
- Directly responsible for nonclinical/clinical aspects of US FDA IND submissions.
- Partner with regional regulatory representatives to confirm CTA requirements as needed (i.e., confirm information provided by CROs)
- Maintain IND/CTAs through end of clinical studies
- Facilitate US clinical trial results postings on CT.gov
- Marketing Applications (MAs):
- Lead the creation of the clinical and nonclinical content of core CTD / global dossier for use in global marketing applications, collaborating with SMEs and regional regulatory representatives.
- Serve as RNC lead on MA Filing Team to support global MA preparation, submission, review through approvals
- Directly responsible for nonclinical/clinical aspects of US marketing applications, maintaining US license and ensuring fulfillment of any PMRs/PMCs
qualifications:
- Degree in health or Life Sciences, including Chemistry, Molecular Biology, or similar. PhD preferred, Master's/Bachelor's acceptable with relevant experience
- 6 + year experience with PhD; 8+ years with Masters or bachelor's degrees
- Deep domain expertise in global Nonclinical / Clinical Regulatory Affairs within the biopharmaceutical industry.
- Proven capacity to lead regulatory strategy development and excel as a key liaison with Health Authorities (e.g., FDA).
- Exceptional strategic mindset with the ability to translate complex science into compelling regulatory arguments for global submissions.
- Demonstrated record of successful global regulatory submissions (IND/CTA/MA) in the Rare Disease space is highly preferred.
skills: Regulatory Affairs Operations, Regulatory Affairs Strategy, FDA Submissions, Health Authority Interaction Management, Response to Deficiency Letters, Electronic Common Technical Document (eCTD), Regulatory Information Management (RIM), Accelerated Approval Pathways, Global Regulatory Strategy Execution
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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 with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
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.
