Senior Manager, Regulatory Affairs, CMC
3 months ago
**General** **Description:**
BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for development of strategies, planning, drafting, and managing CMC-related regulatory submissions and HA interactions to meet the aggressive timelines for the assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics.
**Essential** **Functions** **of** **the** **job:**
Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-approval applications.
Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions, pre-meeting packages, and interactions with Heath Authorities as needed for the assigned project
Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects.
Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle. Escalate the critical issues to senior management timely.
Lead or contribute to development of internal small molecule CMC regulatory guidance and working instructions.
Ensures proper CMC regulatory assessments and actions are taken when recalls or product complaints arise during product lifecycle for the assigned project.
Provide CMC regulatory review for clinical protocols and investigator brochures, etc. for the assigned project.
Provide comments on new global guidance through companys commenting process.
**Computer Skills:** Microsoft 360
**Qualifications:**
+ Bachelor's Degree with 7+ years, Master's Degree with 5+ years, or PharmD/MD/PhD with 3+ years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
+ Small molecule experience required.
+ A proven record of leading Health Authority interactions, CTA, NDA/MAA, post-approval preparation, submission, and subsequent response to HA queries.
+ In-depth knowledge of ICH requirements and US/EU regulatory requirements. Knowledge/experience with regulatory requirements for rest of world regions and GMP regulation is a plus.
+ Demonstrated leadership as a people manager.
+ Experience in authoring complex technical documents, CTD M2 and M3 sections, and life cycle management.
+ Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc.).
+ Excellent oral and written communications skills are a must-have.
+ The candidate should be detail-oriented, a self-motivated, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced environment.
+ Familiarity with Veeva system is a plus.
**Travel:** As needed.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
-
Regulatory Affairs CMC Associate
3 months ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...
-
Regulatory Affairs CMC Associate
3 months ago
San Mateo, United States The Fountain Group Full timeOverview: Prefers the candidate to be local in the Bay Area BUT will consider qualified candidates with Pharma Regulatory CMC experience in the Pacific time zone ONLY. Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for investigational...
-
Regulatory Affairs CMC Specialist
2 weeks ago
San Mateo, California, United States The Fountain Group Full timePosition Overview:We are seeking a qualified candidate with expertise in Pharmaceutical Regulatory CMC to join our team. While preference is given to local candidates in the Bay Area, we are open to considering individuals located within the Pacific time zone who possess relevant experience.Key Responsibilities:Prepare and manage moderately complex...
-
Regulatory Affairs Associate
3 months ago
San Mateo, United States Fladger Assoc. Inc. Full timeJob DescriptionJob DescriptionFoster City, CAContract Duration: 12-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs Associate II in the Foster City, CA area. (Onsite Role)Contractor must meet the company site requirements for the COVID Vaccination PRIOR to starting roleResponsible for the preparation of Drug...
-
Regulatory Affairs Associate
1 month ago
San Mateo, United States Collabera Full timeDescription Home Search Jobs Job Description Regulatory Affairs Associate - II Contract: Foster City, California, US Salary: $60.00 Per Hour Job Code: 352568 End Date: 2024-09-08 Days Left: 28 days, 3 hours left Apply Pay range: $55 to $50/hr.Responsibilities: Collaborate with the RA CMC team to meet deliverables and timelines Ensure data...
-
Regulatory Affairs Associate
1 month ago
San Mateo, United States Net2Source Inc. Full timeNet2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap –...
-
Director of Regulatory Affairs CMC
2 months ago
San Francisco, United States SciPro Full timeDirector Regulatory Affairs CMCSan Francisco, CA (Hybrid)6 month initial contract (likely extension and conversion to FTE)This client is a clinical-stage precision oncology biotech focused on creating cutting-edge therapies to target cancer treatments. Responsibilities:Develop and implement CMC regulatory strategies to facilitate the clinical development and...
-
CMC Regulatory Compliance Associate
2 weeks ago
San Mateo, California, United States The Fountain Group Full timePosition Overview:We are seeking a qualified candidate with expertise in Pharmaceutical Regulatory CMC to join our team. While preference is given to local candidates, we are open to considering individuals located within the Pacific time zone who possess the necessary experience.Key Responsibilities:Prepare and manage moderately complex regulatory...
-
Senior Regulatory Affairs Consultant
2 weeks ago
San Diego, California, United States Katalyst HealthCares & Life Sciences Full timePosition Title: Regulatory Affairs SpecialistCompany: Katalyst HealthCares & Life SciencesEmployment Type: ContractDuration: 12 monthsDepartment: Regulatory AffairsQualifications: Bachelor’s or Master’s degree in a relevant Scientific Discipline At least 7 years of experience in the pharmaceutical sector Minimum of 5 years of experience in CMC regulatory...
-
Regulatory Affairs Specialist
4 weeks ago
San Diego, United States Katalyst HealthCares & Life Sciences Full timeJob Description Job Title: Regulatory Affairs Specialist Company: US Tech Solutions Job type: Contract Duration: 12 months ID: 5175 Department: Regulatory Affairs Prerequisites: BS/BA degree in Scientific Discipline (Masters or higher preferred) A minimum of 7 years in the pharmaceutical industry A minimum of 5 years CMC regulatory (biologics preferred)...
-
Executive Director, Regulatory Affairs
4 days ago
San Diego, United States Regulatory Affairs Professionals Society Full timeBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...
-
Executive Director, Regulatory Affairs
4 days ago
San Diego, United States Regulatory Affairs Professionals Society Full timeBe a part of a global team that is inspired to make a difference in the lives of people living with rare disease.At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because...
-
Regulatory Affairs Specialist
5 days ago
San Francisco, California, United States Pharmatech Associates Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmatech Associates. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our clients' projects with global regulatory requirements.Key ResponsibilitiesCMC and Clinical Regulatory Expertise: You will...
-
Regulatory Data Specialist
1 month ago
San Mateo, United States ACL Digital Full timeJob Title: Regulatory Affairs CMC – Data Administrator ContractorLocation: Foster City CADuration: 12 MonthsDescription:Specific Job Responsibilities Perform data entry using Gilead Information Systems to enter and maintain relevant product information to support cross-functional stakeholders. Work collaboratively to support the RA CMC team to meet...
-
Director, Regulatory Affairs
3 weeks ago
San Diego, United States Pacira Pharmaceuticals Full timeDescriptionAbout PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain...
-
Regulatory Affairs and Compliance Lead
5 days ago
San Diego, California, United States ORIC Pharmaceuticals, Inc. Full timeJob SummaryORIC Pharmaceuticals, Inc. is seeking a highly motivated and experienced Director/Associate Director to lead our Regulatory Affairs and Compliance team. As a key member of our organization, you will be responsible for ensuring compliance with global regulatory requirements and developing strategies to support our clinical development programs.Key...
-
Regulatory Affairs Leader
1 week ago
San Diego, California, United States Radionetics Oncology Full timeAbout Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...
-
Regulatory Affairs Director
1 week ago
San Diego, California, United States Codera Full timeJob DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...
-
Regulatory Affairs Director
1 week ago
San Diego, California, United States Codera Full timeJob DescriptionOverviewCodera, a leading life sciences-focused investment company, is seeking a highly skilled Regulatory Affairs Director to support the development and execution of domestic and international regulatory strategy.Key ResponsibilitiesRegulatory Strategy Development: Provide strategic advice and support the development and execution of...
-
Director, Regulatory Affairs
1 month ago
San Diego, CA, United States Pacira Pharmaceuticals Full timeDescriptionAbout PaciraPacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain...