Sr. Associate Regulatory Affairs
2 days ago
The Opportunity:
The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities.
- Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.
- Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
- Prepare and manage routine submissions and related activities. Define and manage detailed timelines to ensure timely delivery of high-quality, compliant, accurate and complete regulatory submissions.
- Assist in the development and implementation of SOPs and systems to track and manage product-associated events.
- Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
- Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
- Work with manager on acquisition and development of required regulatory skills and knowledge.
Required Skills, Experience and Education:
- Bachelor’s degree in a relevant field.
- Two or more years prior experience in a Regulatory Affairs department at a drug or biologics company.
- Some familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
- Willing to advance my knowledge of regulatory practice through classes, certifications, webinars.
- Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.
Preferred Skills:
- Experience in oncology drug development
- Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA’s
-
Sr. Associate Regulatory Affairs
4 weeks ago
Redwood City, United States Planet Pharma Full timeThe Opportunity:The Senior Associate Regulatory Affairs will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities.Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements,...
-
Senior Associate, Regulatory Affairs
1 month ago
Redwood City, United States REVOLUTION Medicines Full timeRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment...
-
Regulatory Affairs Engineer
2 weeks ago
Redwood City, California, United States Nevro Corp Full timeRegulatory Affairs EngineerNevro Corp is seeking a highly skilled Regulatory Affairs Engineer to join our team. As a Regulatory Affairs Engineer, you'll be responsible for ensuring that our IT systems and processes comply with regulatory requirements, particularly in the FDA-regulated environment (GxP).You'll work closely with our development teams to...
-
Regulatory Affairs Strategist
3 weeks ago
Redwood City, California, United States Nuvig Therapeutics Inc. Full timeAbout the PositionWe are seeking an experienced Regulatory Affairs Strategist to join our team at Nuvig Therapeutics Inc.This role will play a critical part in shaping the regulatory strategy for our clinical and non-clinical programs. The successful candidate will be responsible for developing and implementing global regulatory strategies, ensuring...
-
Director, Regulatory Affairs
3 months ago
Redwood City, United States Nuvig Therapeutics Inc. Full timeWhy Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with...
-
Senior Manager, Regulatory Affairs
1 month ago
Redwood City, United States REVOLUTION Medicines Full timeRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment...
-
Regulatory Affairs Associate
2 weeks ago
New City, New York, United States RK Pharma Inc. Full timeJob Title: Regulatory Affairs Associate - Quality Control We are seeking a highly organized and detail-oriented Regulatory Affairs Associate to join our Quality Assurance team at RK Pharma Inc. and support our efforts in ensuring product quality and regulatory compliance. Main Responsibilities:Assist in reviewing and approving Quality Control...
-
Regulatory Affairs Specialist
1 week ago
Jersey City, New Jersey, United States Axiom Software Solutions Limited Full timeJob DescriptionAs a Regulatory Affairs Specialist at Axiom Software Solutions Limited, you will be responsible for ensuring compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.Key Responsibilities:Represent Regulatory Affairs on cross-functional project teams.Provide technical expertise to cross-functional teams...
-
Senior Director, Regulatory Affairs
4 weeks ago
Redwood City, CA, United States Adverum Biotechnologies Full timeThe Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be...
-
Regulatory Affairs Director
2 weeks ago
Jersey City, New Jersey, United States Futu US, Inc. Full timeAbout the Role:We are seeking a highly qualified Regulatory Affairs Director to lead our compliance efforts at Futu US, Inc.Key Responsibilities:Provide strategic guidance on regulatory matters to ensure compliance with applicable laws and regulations.Develop and implement effective compliance programs to mitigate risks and maintain a strong...
-
Director of Regulatory Affairs
1 week ago
Bossier City, Louisiana, United States LOUISIANA DOWNS INVESTMENT COMPANY LLC Full timeDirector of Regulatory AffairsAnnual Compensation: $105,000 - $130,000.About the RoleWe are looking for a highly skilled Director of Regulatory Affairs to join our team at Louisiana Downs Investment Company LLC. This individual will be responsible for overseeing the development and implementation of our regulatory compliance program, ensuring that we...
-
Regulatory Affairs Coordinator
1 week ago
Oklahoma City, Oklahoma, United States Red River Science & Technology Full time**Job Title:** Regulatory Affairs Coordinator**Company Overview:** Red River Science & Technology is a leading provider of training, logistics, and technology solutions. We strive for excellence in meeting our customers' needs both CONUS and OCONUS.**Job Description:**We are seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a...
-
Packaging Regulatory Affairs Professional
6 days ago
Story City, Iowa, United States American Packaging Corporation Full timeJoin Our TeamWe are seeking a talented Packaging Regulatory Affairs Professional to join our team at American Packaging Corporation. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with US and Global regulations for customer products.About the RoleThis position reports directly to the Corporate Regulatory...
-
Regulatory Affairs Professional
1 week ago
Jersey City, New Jersey, United States Axiom Software Solutions Limited Full timeAxiom Software Solutions Limited is looking for an experienced Regulatory Support professional to support our regulatory operations. The ideal candidate will have a solid understanding of regulatory affairs and experience working with Veeva RIM Submission/Archive, Publishing etc.The estimated salary for this position is $140,000 - $200,000 per year,...
-
Regulatory Affairs Specialist
1 week ago
Bossier City, Louisiana, United States LOUISIANA DOWNS INVESTMENT COMPANY LLC Full time**About Us:**Louisiana Downs Investment Company LLC is committed to providing exceptional gaming experiences for our patrons. We are seeking a highly skilled Regulatory Affairs Specialist to join our team and play a critical role in ensuring compliance with relevant laws and regulations.The estimated salary for this role is $90,000 - $130,000 per year, based...
-
Senior Director of Regulatory Affairs
4 months ago
New York City, United States MetroPlusHealth Full timeEmpower. Unite. Care.MetroPlusHealth is committed to empowering New Yorkers by uniting communities through care. We believe that Health care is a right, not a privilege. If you have compassion and a collaborative spirit, work with us. You can come to work being proud of what you do every day.About NYC Health + HospitalsMetroPlusHealth provides the highest...
-
Regulatory Affairs Manager
6 days ago
Kansas City, Missouri, United States Environmental Works Inc Full timeJob DescriptionAs a Regulatory Affairs Manager at Environmental Works Inc, you will be responsible for managing nationwide clients on a team, overseeing sampling and analytical data evaluation for various media, and completing documentation of field activities.You will also be required to serve as a leader during field activities with junior...
-
Regulatory Affairs Coordinator
4 weeks ago
Salt Lake City, United States ARUP Laboratories Full timeDescription Schedule :Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PM Department: Corp Compliance Office - 241 Primary Purpose : The Regulatory Affairs Coordinator is a member of the Corporate Compliance office and supports the Public Health Reporting team and Compliance Manager. The Regulatory Affairs Coordinator ensures compliance to new and existing...
-
Regulatory Affairs Specialist
3 weeks ago
St. Louis City County, United States Randstad Enterprise Full timeRandstad has an immediate opportunity for a Regulatory Affairs Specialist to work with a global leader in agricultural research. This is a hybrid position located in St. Louis, MO. Local candidates are preferred as relocation cost reimbursement is not available for this postion.What you will do:Manage the state regulatory activities necessary to obtain and...
-
Regulatory Affairs Professional
1 week ago
Jersey City, New Jersey, United States Volt Full timeAbout the JobInnova Solutions is hiring a Regulatory Affairs Professional to work in Lawrence Township, NJ. As a Medical Scientist, you will play a key role in maintaining therapeutic area and product knowledge through ongoing assessment of relevant published literature, treatment guidelines, internal resources, and data.Key ResponsibilitiesDevelop and...