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Abdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to s
Job Source: Abdera TherapeuticsAbdera Therapeutics
South San Francisco, CA, United States
Salary Range : US$ 200K - $270K Who we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes
Job Source: Abdera TherapeuticsAlumis Inc.
South San Francisco, CA, United States
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motiv
Job Source: Alumis Inc.Maze Therapeutics
South San Francisco, CA, United States
The Position: Join our dynamic Regulatory Affairs team as a Director, Regulatory Affairs, where you will be the driving force behind our development programs from preclinical candidate designation through drug approval. We are looking for a strategic thinker and regulatory expert to provide leadership and guidance. As the Global Program Lead, you
Job Source: Maze TherapeuticsBioSpace, Inc.
South San Francisco, CA, United States
Job Details Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an except
Job Source: BioSpace, Inc.Alumis Inc
South San Francisco, CA, United States
Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. We are seeking an exceptionally motiv
Job Source: Alumis IncGenentech
South San Francisco, CA, United States
The Position The Opportunity: This Job is an Individual Contributor position. In the position of Regulatory Program Director in Roche / Genentech Pharma Technical Regulatory (PTR), you will be accountable for Health Authority interactions pertaining to CMC Information (i.e.: CMC information in an IND, IMPD and NDA/BLA/MAA filings), as well as in
Job Source: GenentechBioLink 360
San Francisco, CA, United States
Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help
Job Source: BioLink 360Oakland, CA, United States
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We seek enthusiastic, resilient professionals to join Dompé’s US regulatory affairs department.The candidate reports to the Global Regulatory Affairs Senior Director and will play an important role within the Regulatory Affairs organization.
As one of the team members for Regulatory Affairs in Dompé, you will
Support the global regulatory affairs senior director in executing regulatory strategies for the assigned post-approval projects for US and ex-US countries (Europe, Switzerland, Canada, China, Australia).
Prepare and deliver high-quality post-approval changes such as PAS, CBE-30, CBE-0 related supply, and label update submission for the approved BLA
Review and evaluate change control to provide a regulatory assessment
Conduct a thorough review of safety submissions such as DSUR, PSUR, and IND-safety reporting for the combination product (biologics-device) and perform health authority submission within the allocated deadline globally
Maintain DUNS, FEI, establishment registration for the combination product
Collaborate with cross-functionally for annual report preparation globally
Coordinate with external vendors to maintain registration and life-cycle of assigned products globally
Support late-phase post-approval studies, i.e., protocol review, IND submission, maintenance, CSR review, and publication review
Conduct a regulatory review of the medical, scientific exchange, educational material, and corporate communication for the congresses in the US
Proactively prioritize and complete multiple projects within the established deadline
Maintain awareness of evolving FDA and international regulations and interpretation, competitive landscape, regulatory precedents, real-world data/evidence to support labeling expansions, etc.
We seek team members who will live by and promote the core values of our Dompé culture: integrity, speed, knowledge, passion, attention to detail, reliability, flexibility, and teamwork. We are looking for individuals with an entrepreneurial spirit, flexible attitude, and adaptable nature to join our team.
YOU COULD BE THE PERFECT FIT IF YOU HAVE: Doctorate degree and 10+ years in the pharmaceutical, biotech, or related industries and 8+ years of regulatory affairs
Master’s degree and 12+ years in the pharmaceutical, biotech, or related industries and 10+ years of regulatory affairs
Bachelor’s degree and 14+ years in the pharmaceutical, biotech, or related industries and 12+ years of regulatory affairs
Post-approval and life-cycle management
Previous experience with Veeva is preferred
Strong understanding of US regulations
SKILLS YOU’LL NEED FOR SUCCESS: TECHNICAL Excellent professional and regulatory writing skills
Strong communication skills and effective cross-functional collaboration (CMC, clinical operation, supply, quality, compliance, medical affairs, clinical development, legal, HR, etc.)
In-depth knowledge of late-stage clinical development
Exceptional experience in post-approval submissions
Prepare and submit high-quality regulatory submissions (coordinating with regulatory operations)
Give direction to a cross-functional team to guarantee regulatory compliance with internal SOPs and FDA requirements, including compilation and submission of any required documents to regulatory agencies
Maintains up-to-date knowledge of laws, regulations, and policies enforced by the FDA and provides regulatory advice accordingly
Risk assessment and appropriate escalation to the line manager and senior leadership team.
SKILLS YOU’LL NEED FOR SUCCESS: PERSONAL Expertise in authoring regulatory documents
Flexibility and use an approach based on the need and common sense to be a real problem solver.
Commitment to thrive in a fast-paced and challenging environment and is able to balance multiple priorities effectively.
Ability to maintain accuracy and attention to detail while meeting deadlines for assigned projects and daily activities.
Ability to work independently, self-starter.
Base Salary: $180,000 - $235,000 a year
At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland
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Email Alert for Regulatory Director jobs in Oakland, CA, United States
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