As Head of RA, responsible for both US and China RA's pipeline products to be registered with a good time manner.
- Join a Biopharma company providing innovative therapeutics to patients globally
- Opportunity to be the Head of RA for both US and China pipelines
Oversees (CMC) submissions (IND, IMPD, CTA) content for biologics development programs. Represents Regulatory Affairs and provides strategic input for CMC team activities supporting an emerging portfolio of biologics products.
- Join a clinical-stage company focused on devastating diseases
- Opportunity to be the Head of Regulatory Affairs at a growing company
Director of Regulatory Compliance serves as regulatory expert in keeping the company's compliant with regulatory requirements pertaining to OTC, Dietary Supplement, Homeopathic, and Cosmetic product categories. Ensures product labeling, claim substantiation, product registration, facility registration and licenses are current and meet regulatory requirements. Provide regulatory guidance and insights to cross-functional teams.
- Join a Leading Consumer Health Company
- Join a Trusted Brand with Rich History
The Senior Regulatory Affairs Specialist will be responsible for product submissions, periodic updates, and registrations to regulatory agencies. This individual will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings, and research regulatory issues and provide guidance and advice to colleagues.
- Oppertunity for substantial growth in Regulatory Department
- Expanding medical diagnostics/IVD company based in Southern NH
Remote position** The Sr. Manager, RA will be a key member of the Regulatory Tea,, partnering and facilitating regulatory activities for assigned products. They will support and lead the development of regulatory strategies.
- Join a clinical-stage company dedicated to medicines in devastating diseases
- Looking for an experienced Manager in Regulatory Affairs
The Executive Director of Regulatory Affairs will proactively develop and execute creative and thorough global regulatory strategies for assets in clinical development through collaborative partnership and regulatory leadership within the project team.
- Disruptive clinical stage biotech with extremely diverse and robust pipeline
- Full-time remote opportunity with publically traded organization
The Executive Director of Regulatory Affairs will proactively develop and execute creative and thorough global regulatory strategies for assets in clinical development through collaborative partnership and regulatory leadership within the project team.
- Disruptive clinical stage biotech with extremely diverse and robust pipeline
- Opportunity to work full-time remote for publically traded organization
The Director of Global Regulatory Affairs will define company regulatory strategy for biologic and small molecule programs, overseing regulatory matters and lead all regulatory initiatives.
- Join a high growth, well-financed biotech organization focused on orphan drugs
- Own and develop global regulatory strategy for program pipeline
Our client is an established Medical Device Manufacturer that has been in business for many years. They seek a Regulatory Affairs Manager that will report to their US Head of Regulatory. Their site has over 300 employees, with a total of 225 throughout North America. This is a new position due to continued growth and product development.
- Employee-centric culture focused on development and progression
- Average Employee tenure over 10 years
The Associate Director, Regulatory Affairs will join a growing team in charge of regulatory activities for a diverse product pipeline related to CMC for all global markets, but with a focus on the EU and US area.
- Opportunity to join a rapidly growing biotech company
- Work on extremely diverse and robust product pipeline
The Senior Director serves as the regulatory lead for relevant product program teams and will manage other members of the regulatory affairs organization. This includes supporting the VP of Regulatory Affairs in ensuring the development, implementation and alignment of regulatory strategy across programs.
- Work on extremely diverse and robust product pipeline
- Opportunity to work remotely for publicly traded organization
The VP of Regulatory Affairs will develop and execute the global regulatory strategy for our client's product pipeline and provide strategic leadership to oversee and direct all regulatory activities through early and late stage development.
- Exciting opportunity to build out Regulatory function at high-growth start up
- Own Regulatory aspects of programs approaching the clinic in both US and China
The Director, Regulatory Affairs, CMC is responsible for the submission of INDs, NDAs, BLAs, as well as other regulatory submissions for CMC topics as required in collaboration with appropriate leadership.
- Join a growing biopharma company focused on Oncology
- Great opportunity to oversee a team changing the lives of cancer patients
The role requires significant experience and proven success with developing and executing regulatory strategies for complex drug development programs. The Senior Director serves as the regulatory lead for assigned product program teams and will manage other members of the regulatory affairs organization.
- Join a biotech company developing medicines for devastating diseases
- Exciting opportunity to serve as lead of Regulatory
The Associate Director, Regulatory Affairs will oversee regulatory activities for product programs and support and lead development of regulatory strategies. This role will execute program strategies and deliverables working in collaboration with relevant internal stakeholders.
- Opportunity to join a rapidly growing and publicly traded biotech organization
- Work on extremely diverse and robust product pipeline
Our client is an established Medical Device Manufacturer that has been in business for over 75 years. They seek a Director of Regulatory Affairs that will report directly to the President of the organization. This company boasts a brand new state of the art facility with a full cafeteria, gym, and other ammentities on site. They also continually grow in revenue and have a product line sold in every major retailer.
- Lead the Regulatory Affairs department and report directly to the President
- 20% bonus eligible
Our client is an established Medical Device Manufacturer that has been in business for over 75 years. They seek a Director of Regulatory Affairs that will report directly to the President of the organization. This company boasts a brand new state of the art facility with a full cafeteria, gym, and other ammentities on site. They also continually grow in revenue and have a product line sold in every major retailer.
- 20% bonus eligible
- Lead the regulatory affairs department for a massive medical device manufacturer
Our client is an established Medical Device Manufacturer that has been in business for many years. They seek a Regulatory Affairs Manager that will report to their US Head of Regulatory. This is a new position due to continued growth and product development.
- 31 Days of Time Off per year
- Remote work flexibility
The Head of Regulatory Affairs will oversee Regulatory Affairs and provide strategic input for CMC team activities for the development of submissions content and strategy for biological products.
- Opportunity to join a high growth, publicly traded biotech organization
- Represent Regulatory Affairs CMC for emerging portfolio of biologics products
A qualified Sr. Regulatory Affairs Specialist will oversee all regulatory functions for both international and domestic affairs. This person will be in charge of providing guidance for all regulatory affairs, record keeping, and reviewing all dietary supplement labels.
- Growth opportunity in dietary supplement manufacturing
- Well established brand
Our client is an established Medical Device Manufacturer that has been in business for over 100 years. They seek a Regulatory Specialist that will report to their US Head of Regulatory. Their site has over 175 employees, with a total of 225 throughout North America. Their products serve urology, surgery, gynecology and spine surgery.
- Work fully remotely
- Growing company, amazing benefits package
Our client is a manufacturer of endoscopic instruments located in Lincolnshire, IL. They are looking to bring on a Regulatory Affairs Specialist to the expanding team due to year over year revenue and employee growth. This person will report directly to the US Head of Regulatory Affairs/ Quality Assurance and be heavily involved in strategy related to the regulatory affairs direction.
- Excellent work life balance
- Report directly to the US Head of Regulatory Affairs
Provide scientific advice to high level stakeholders using scientific research and analysis. Advise on policy drafting with relation to emerging technologies and scientific advancements and explain complex concepts in a simple manner.
- Opportunity to advise stakeholders on science, technology and innovation
- Must have extensive experience in research and policy advisory
The Regulatory Compliance Manager will be a key member within the organization, providing global regulatory and product compliance oversight of all existing and new products.
- Competitive Compensation Up to $140k
- Room for Professional Growth
This is a Project Manager position located within the Regulatory Affairs Department
- Highly reputable financial corporation
- High growth potential
The Senior Quality Manager will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations.
- Run the Quality Department at a Hands-On Manufacturer specializing in ISO13485
- High visibility position with an organization that promotes internal growth
The Director/Sr Director, Regulatory CMC Biologics will oversee Regulatory Affairs and provide strategic input for CMC team activities for the development of submissions content and strategy for biological and cell and gene therapy products.
- Opportunity to join a high growth, publicly traded biotech organization
- Own Regulatory CMC for diverse portfolio of biologics and CGT products
Join our client which has 28+ products in their portfolio and are commercialized in 90+ countries.
Reporting to the SVP of Clinical, Regulatory, and Quality Affairs, The Director of Quality will be responsible for the overall performance of our multiple departments within Quality. The scope of the position will have responsibilities including quality control, compliance, quality engineering, life cycle engineering, and post market surveillance.
- Join a fast growing mid-sized Medical Device company
- Limitless Growth Opportunity
The Senior Quality Manager will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations.
- Run the Quality Department at a Hands-On Manufacturer specializing in ISO13485
- High visibility position with an organization that promotes internal growth
The Senior Quality Manager will provide overall company leadership and direction for Quality Assurance and Regulatory Affairs Systems, encompassing both improvements and sustaining activities. Objectives involve ensuring patient and employee safety and the achievement of customer quality requirements, create, monitor and improve quality systems/programs, and reduce quality costs for + $40 million in annual sales.
- Leadership opportunity in one of biggest Precision Manufacturers in the Market
- Terrific Growth Opportunity
