- Develop and implement Regulatory Affairs strategies and tactical work plans during clinical development and in preparation for the anticipated US filings.
- Identifying and assessing regulatory risks, understanding global imperatives including market-related drivers.
- Accountability for overseeing regulatory submissions for the oncology portfolio, including the associated communication strategy to all regulatory authorities.
- Ensure that sound regulatory practices are fully integrated into pre-clinical, clinical and technical submissions, and will ensure that all documents submitted to regulatory agencies are appropriately reviewed to ensure they are complete, scientifically accurate, and of high quality.
- Contribute to the creation and implementation of development plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications, delivering regulatory approval and reimbursement for all key indications.
- Act as a credible, influential, respected spokesperson during interactions with US and international regulatory agencies, and ensure appropriate, proactive communication with agencies to assure expedient and efficient review and approval of submissions.
- Monitor and anticipate regulatory & Scientific Advances, novel end-points, innovative clinical trial designs and regularly brief company management.
- Present and defend regulatory plans to Senior Management.
- Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, BLAs, fast-track/breakthrough/accelerated approval/orphan drug applications.
- Fulfill all requirements for ensuring all reporting obligations are met, including amendments, annual reports to FDA, safety and quality reports.
- Collaborate with Medical to manage the regulatory aspects of the company Pharmacovigilance system including the establishment and review of SOPs and providing the regulatory oversight of the system managements and reporting requirements.
- Collaborate with Product Development, Manufacturing and Quality to manage regulatory aspects of all CMC activities. Perform regulatory evaluation of CMC change controls.
- Participate or lead regulatory interactions with and presentations to US FDA and other regulatory agencies.
- Review and approval of Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, and ISS.
- Represent Regulatory Affairs on cross-functional teams. Interact collaboratively with CMC, clinical, pre-clinical, supply chain, operations and other functional management as they impact the quality of products and operations.
- Evaluate and approve documentation for regulatory filings.
- Use considerable analytical and judgment skills to drive continuous improvements.
- Hybrid work schedule: 2-3 days in office are required.
- MS/PhD or MD in Life/Health Sciences.
- A proven leader with a minimum of 10+ years pharmaceutical/biotechnology industry experience in multiple phases of development (must have both large and small company experience), 10+ years regulatory experience in biotech programs.
- MUST HAVE BIOLOGICS EXPERIENCE
- Recent experience of IND, NDA and BLA submissions a must.
- Deep knowledge and understanding of drug development process, regulatory requirements and environment, especially in the US.
- Demonstrate strategic thinking and implementation in overall drug development, with experience in orphan diseases.
- Demonstrated strategic capability and ability to see the overall, 'big' picture, along with examples of showing courage and confidence to lead and implement change
- Ability to read, analyze and interpret complex regulatory documents and to respond effectively to sensitive inquiries or complaints
- Able to drive strategic thinking and plans for successful regulatory outcomes.
- Dynamic individual with excellent written and communication skills.
- Ability to set priorities, work independently and deliver results in a timely manner.
- Experience in interfacing with regulatory authorities.
- Strong planning, organizational and leadership skills.
- Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment.
- Attention to detail.
- Thorough understanding of the FDA (biologics division), including experience in PAI readiness
- Results oriented. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
- Experience in radiopharmaceuticals is a major plus.
-
Regulatory Affairs Specialist
3 weeks ago
Hologic Newark, United StatesHologic is seeking a **Regulatory Affairs Specialist** to join our expanding Innovation Center located in Newark, DE. · **What to Expect**: · The **Regulatory Affairs Specialist **is expected to perform the coordination and preparation of document packages for regulatory submissi ...
-
Regulatory Affairs
2 days ago
Propper Manufacturing Company Long Island City, United States**Overview**: · The RA/QA Associate will work under the direct supervision of the Director - RA/QA. The RA/QA Associate will be responsible for (but not limited to) the following tasks: · - Support the operation and continuous improvement of the Quality Management System. · - Rev ...
-
Us Chemical Regulatory Affairs
1 week ago
W.L. Gore & Associates Newark, United States**About the Role**: Our Performance Solutions Division is looking for a Chemical Regulatory Affairs associate to join the team. Chemical Regulatory Affairs provides expertise on chemicals and associated regulations. In this role, you will focus on US and Canadian chemical control ...
-
Regulatory Affairs
3 weeks ago
iRiS Recruiting Solutions New York, United StatesRegulatory Affairs · Regulatory Affairs SME · Compensation: $110,000 to $130,000 · Location: Shelbyville, IN · ABOUT OUR CLIENT: · Our client is a leader in their space, in SE Indianapolis. Their state-of-the-art facility will · be where groundbreaking ideas become reality. Thei ...
-
Regulatory Affairs
2 weeks ago
AA2IT New York, United StatesJob Title: Regulatory Affairs - Animal Health · Location: Rahway, NJ - Onsite from day 1 · Pay Rate: $42/hr · Duration: 11 Months · We are inviting applications for the role of CMC 2 Regulatory affairs. · Responsibilities: · Well versed in performing CMC compliance activitie ...
-
Regulatory Affairs
3 weeks ago
Marubeni America New York, United States**Regulatory Affairs & Customer Service Manager - Agri-Input Dept. - Agri Input Unit** · MAC Agri Input Unit HARR 500 Mamaroneck Avenue, 500 Mamaroneck Avenue, Harrison, New York, United States of America Req #33 Thursday, January 27, 2022 Marubeni America Corporation Regulatory ...
-
Regulatory Affairs Specialist
3 weeks ago
Symrise Saddle Brook, United States**About Us** · Symrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. · Its sales of € 4.6 ...
-
Regulatory Affairs Officer
3 weeks ago
Brio Group New York, United StatesJob Title: · Regulatory Affairs Officer · Company: · Biopharma Organization · Location: · Hybrid, RTP Area · Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO i ...
-
Regulatory Affairs Specialist
3 weeks ago
BioTalent New York, United StatesPosition Summary · The primary responsibility of the Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The RAS is also responsible for ensuring products and procedures comply with regulatory agency specifica ...
-
Regulatory Affairs Consultant
3 weeks ago
Connect Life Science New York, United StatesRegulatory Affairs Consultant · Cambridge MA, Remote with occasional site time · Medical Device · 6 month contract - 40 hours per week · Competitve hourly rate · A MedTech company based in Massachusetts specializing in Class 2 Medical Device solutions are looking to hire a contr ...
-
CUSO Regulatory Affairs
1 week ago
Credit Agricole New York, United StatesSummary: · The Regulatory Affairs team is responsible for coordinating and facilitating communications between the Bank and its various regulators on behalf of all US business operations and entities, as well as for coordinating the regulatory remediation efforts within the regio ...
-
Regulatory Affairs Specialist
3 weeks ago
ACE Partners New York, United StatesMy client are looking for a Regulatory Affairs Specialist with experience in Asia Pacific Product Registrations. · You · MUST · be willing to work hybrid in office at Exton, Pennsylvania. · Essential Duties and Responsibilities: · Author and review China, South Korea, Japan a ...
-
VP of Regulatory Affairs
3 weeks ago
Leaman Life Sciences New York, United StatesVP of Regulatory Affairs · I am partnered with a scientifically driven late-stage, well funded biopharmaceutical company who are looking to build out their Solid Tumors pipeline. · They are looking for a Vice President of Clinical Regulatory Affairs to be responsible for the dev ...
-
Director of Regulatory Affairs
4 weeks ago
X4 Life Sciences New Jersey, United StatesA long-term international consulting client of X4 Life Sciences is looking to add a Director, Regulatory Affairs to their rapidly growing team. · Our client focus on providing their clients with solutions to their most difficult drug development challenges whilst providing unique ...
-
Regulatory Affairs Officer
2 weeks ago
Brio Group New York, United StatesJob Title: · Regulatory Affairs Officer · Company: · Biopharma Organization · Location: · Hybrid, RTP Area · Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO ...
-
Regulatory Affairs Specialist
3 weeks ago
Nihon Kohden New York, United StatesThe Regulatory Affairs Specialist temp is responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization's products. Work with RA Leadership and other members of the RA team ...
-
Director of Regulatory Affairs
3 weeks ago
TGI Life Sciences New York State, United StatesAre you passionate about revolutionizing healthcare through innovative medical devices and cutting-edge AI technology? We are seeking a dynamic and experienced Director of Regulatory Affairs to join our team in the vibrant San Francisco Bay Area. If you thrive in a fast-paced en ...
-
Director of Regulatory Affairs
2 weeks ago
Metropolitan Commercial Bank New York, United StatesCome work with us: · Metropolitan Commercial Bank (the "Bank") is a New York City based full-service commercial bank that provides a broad range of business, commercial and personal banking products and services to individuals, small businesses, private and public middle-market ...
-
Regulatory Affairs Specialist
3 weeks ago
Kelly Science, Engineering, Technology & Telecom New York, United StatesKelly Science & Clinical is seeking a · Regulatory Affairs Ops Specialist near Round Lake, IL. · Long term contract = ~1 year contract · Shift: · Monday - Friday 1st · Hybrid - 3 days onsite, 2 remote · Compensation : based on experience · Responsibilities: · Managing the pre ...
-
Regulatory Affairs Manager
2 weeks ago
Amika New York, United Stateshi there, we're amika. a friend to hair, hairstylists, her, him, them, + you. amika means friend in the language esperanto and is a symbol of our belief in the power of community + the beauty of diversity. · brooklyn-born + salon raised: where creativity + culture is a way of li ...
VP, Regulatory Affairs - New York, United States - Scismic Inc
Description
Job Description
Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs.
Their vision is to build a specialty, hospital-focused radiotherapeutics company that develops and markets medicines for relapsed or refractory cancer patients who are treated primarily in large quaternary care hospitals and their catchment areas. On the basis of results that demonstrate meaningful survival benefit and provide the opportunity to move the goal post in AML, the company intends to launch two drugs in five years.
The company is well-funded. Their differentiated product pipeline is further exemplified by their next-generation program for rapidly growing cell and gene therapies, as well as their solid tumor and immunotherapy collaborations with several large companies. In addition, they have several other programs in solid tumors at the pre-clinical stage with IND-enabling studies ongoing and their extensive intellectual property portfolio includes over 200 issued patents and pending patent applications worldwide.
Job Overview:
The incoming VP of RA will be a leader and key member of a dynamic team who is responsible for developing, directing and implementing the regulatory strategy for several programs with a focus on unmet medical needs in oncology. The VP will identify the key strategic regulatory drivers for early and late stage programs for submissions (from IND to BLA) to US and international regulatory agencies. This position also will be responsible for developing, establishing and maintaining effective relationships with regulatory agencies, especially the FDA, EMA and overseeing all Regulatory Affairs activities. The incoming candidate must have significant regulatory expertise in Oncology drug development with a demonstrated track record of success in terms of biologics drug approvals.
This role reports to CMO.
Key Responsibilities:
Qualifications:
Compensation will be commensurate with experience. The company offers competitive base salaries, performance bonuses, equity incentive plans, 401(K) with company matching and comprehensive health benefits.