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Head Of Regulatory Affairs Jobs

Director Of Regulatory Affairs
By Trebla Talent At Greater Chicago Area, United States
Strong knowledge of current drug development regulations and guidelines including ICH, FDA and EMA guidelines; NDA experience is required.
Minimum of 10 years of experience across Regulatory Affairs or another transferrable function in biotech/pharma
Both clinical and CMC experience is desired
Bachelor’s degree is required; advanced degree is preferred.
A passion for the psychedelic and mental health industry
Director/Senior Director of Regulatory Affairs
Assistant Director Of Regulatory Affairs
By NC Real Estate Commission At West Bend, NC, United States

Attorney needed to assist division director with supervisory and managerial responsibilities and to prosecute cases involving allegations of violations of Real Estate License Law and Commission ...

Director Of Regulatory Affairs
By Tabseer | تبصير At Dallas, TX, United States
-Thorough knowledge of relevant regulatory laws, guidelines, and industry standards in Products Certification and Inspection Activities.
-Excellent communication and negotiation skills to articulate regulatory requirements and advocate on behalf of Tabseer.
-Good relationship with top level of Saudi Regulators’ Management Team.
Job Title: Regulatory Affairs Manager
-Clarify any ambiguous regulatory points or requirements by engaging with regulators and coordinating with internal teams.
-Stay informed about changes in regulatory landscape and assess their impact on Tabseer's certification and inspection operations.
Director Of Regulatory Affairs
By Lumicity At United States
Experience with documentation and lifecycle management within the biotechnology industry preferred
Effectively communicate the regulatory strategy, risks mitigation, and overall plans to program teams and senior management
Knowledge of regulatory requirements across development stages
Manage filings of necessary regulatory documents and manage lead meetings with regulatory agencies and other reviewing bodies
Identify applicable regulatory requirements for conducting clinical trials
Manage and help negotiate the regulatory activities of contract research organizations, consultants, and contractors in the preparation of regulatory submissions
Manager Of Regulatory Affairs
By Connect Life Sciences At Washington DC-Baltimore Area, United States
Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
Provides regulatory and project management support for projects as needed.
Superior organizational skills and customer service abilities.
Strong working knowledge of Microsoft office; experience with SharePoint a plus.
Supervises and manage Regulatory Team staff members, as assigned.
Head Of Corporate Affairs
By Nimbus Therapeutics At Boston, MA, United States
Exceptional written, oral, interpersonal and presentation skills, and experience interfacing with and serving as communications advisor to C-suite.
Lead corporate thought leadership campaigns that further augment organizational reputation and manage risk.
10+ years of progressive biopharma communications experience, including in a senior leadership role; combination of PR agency and in-house experience preferred.
These qualifications will help this role be successful:
Update and maintain Nimbus' corporate narrative and branding.
Provide strategic counsel to our leadership team on matters related to corporate communications and affairs.
Director Of Regulatory Affairs
By Sterling-Hoffman Life Sciences At Richardson, TX, United States
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the nutraceuticals industry is strongly preferred
4) Preference will be given to candidates with recent experience in regulatory affairs
4) Help the Regulatory Affairs Team apply complex regulatory concepts to projects in an easy-to-understand manner
5) Understand the interrelationship between labeling, artwork, and product regulations
8) Maintain regulatory records and files
Director Of Regulatory Affairs - East
By Carter Maddox At United States
In coordination with functional groups, manage policy and filing priorities.
Able to manage consultants to assist where necessary.
Experience in the renewable energy sector.
Strong experience in the regulatory process at state and federal level with a proven track record.
Exceptional analytical skills in understanding policy impacts to energy development and pricing.
Advanced level of education in policy is preferred but not required.
Director Of Regulatory Affairs
By Hemab Therapeutics At Boston, MA, United States
Direct point of contact with health authorities, leads and manages Regulatory Agency meetings, in cooperation with outsourced vendors.
Bachelors degree in a scientific subject area coupled with sufficient industry experience. Advanced degree (e.g. MSc, PhD, PharmD, MD) preferred.
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates with influence in or leads departmental and cross-functional taskforces and initiatives.
Head Of Training, Quality & Regulatory
By ADMA BioCenters At Roswell, GA, United States
Ten (10) years of management experience demonstrating increasing levels of competency and responsibility, preferably in the Plasma and/or FDA regulated industry.
Management oversight of Quality Systems, Documentation, and CAPA’s.
Develop risk management controls and systems.
Proficiency in Learning Management System(s)
Effective manager with ability to mentor and develop members of the QA/RA/Training teams through coaching and effective performance management.
Manage budget, CAPEX, and financial responsibilities for each cost center, projects, and programs.
Head Of Regulatory Affairs
By Life Science People At Torrance, CA, United States
Proven people management experience, with a track record of building and leading high-performing teams
Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
Excellent writing, communication, and interpersonal skills
Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
Director Of Regulatory Affairs (Cell Therapy)
By GQR Global Markets At San Francisco Bay Area, United States
Assist in organization and management of staff within the RA group, including coaching, career development and oversight of work, as required.
Depth Knowledge of GLP and GCP regulatory requirements in domestic and globally.
Manage all aspects of nonclinical and clinical regulatory strategy development for products (early- to late-stage/registration/post-market).
Prior experience with cell or gene therapies (preferred)
Prior experience in oncology drug development
10+ years working within the biotech/pharmaceutical industry. 8+ years of pharma and/or biotech regulatory CMC-experience.
Chief Of Regulatory Affairs
By Idea Evolver At Philadelphia, PA, United States
10+ years of experience in Regulatory and Quality management, preferably in the SaMD space. ACNU expertise is a huge bonus.
Overseeing CAPA, Change Management, Internal and External Audits, Management Review & Post-Market Surveillance needs.
Overseeing QA/RA team to provide support for ensuring company compliance with all applicable quality, regulatory, & statutory requirements.
Responsible for ensuring compliance to Design Control & SDLC process requirements at a project level.
Experience working with medium to large-sized businesses in a client-facing role.
Highly motivated, independent individual with strong organizational skills and a thorough attention to detail.
Sr. Director Of Regulatory Affairs
By Simply Biotech At North Carolina, United States
10+ years of management experience in Regulatory with direct reports.
Responsible for the preparation and management of IND, BLA, 510(k) and/or other appropriate market authorization applications for existing and new products
Knowledge of FDA, Health Canada (HC) and United States Department of Agriculture (USDA) guidelines and requirements
5+ years of Pharmaceutical Industry Experience
Experience submitting to the FDA, HC, and USDA
Experience reviewing, revising, and authoring INDs, BLAs, and 510(k)s
Head Of Regulatory Affairs - Igt-D
By Philips At , San Diego, Ca
Extensive experience and knowledge required of global medical device regulations, requirements, and standards;
Leading strategic AOP management to optimize revenue
10 years of people management – with a strong track-record in successfully leading a Regulatory Affairs team
Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);
*Montana employees are currently excluded from this requirement at this time.
In return, we offer you
Head Of Regulatory Affairs
By Albion Rye Associates At Boston, MA, United States
Education, Qualifications, Skills & Experience:
Knowledge of Regulatory Affairs, working with products in early and late stages of clinical development
Experience working within Regulatory Affairs on a global level
Lead cross-functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
Lead a Global Regulatory Team
Deliver regulatory milestones on your team including an assessment of risks and mitigation, emerging data, and the probability of success.
Vice President Of Regulatory Affairs
By Charlton Morris At United States
5+ years’ medical device Regulatory Affairs experience with ophthalmic devices.
Proven success in a Regulatory leadership position (Senior Manager’s & Manager’s will be considered)
Experience working internationally and available to travel
Proven track record with PMA, 510(k), EUMDR, FDA.
Educated to Bachelor’s degree level in a related discipline.
Be instrumental in launching a disruptive device that will create a new gold standard in patient care
Vice President, Head Of Regulatory Affairs And Quality Assurance
By Scorpion Therapeutics At , Boston, 02114, Ma
Ensure the qualification, selection and management of vendors and contractors through a defined qualified process
Design and maintain a fit-for-purpose quality management system (QMS) across the GxPs
Develop and manage Global Regulatory Affairs and QA budgets
Extensive experience leading, designing, writing and submission of regulatory filings and correspondence
Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities
Strong problem solving, critical thinking and analytical skills, required to make sound decisions
General Manager/Avp – Head Of Regulatory Affairs - North America
By Biocon Biologics At United States
Minimum 20 years relevant experience out of which more than 10 years of the people manager role
Proven US & CA regulatory affairs experience
Excellent leadership and communication skills,
Negotiation & liaising experience with US FDA and Health Canada.
Brings together US/CA regulatory requirements to derive the global development strategy partnering with GRL (Global Regulatory Lead).
Responsible for all aspects of the US/CA regulatory strategy for approved products and products under development.
Head Of Public Affairs
By GE HealthCare At Connecticut, United States
Strong project management skills and proven track record of accomplishments
Broad and deep experience with and knowledge of print, video and social media and key drivers, metrics associated
10-15 years of communications and media relations experience covering crisis communications, PR or marketing communications, and global public affairs
Healthcare experience & experience in government/political campaign, corporate communications, or public relations preferred
Experience/comfort with data measurement, from polling to grassroots campaigns or other work with a strong data component preferred
Demonstrated experience acting as a trusted advisor to senior level executives

Are you looking for an exciting opportunity to lead a team and shape the future of regulatory affairs? We are looking for a Head of Regulatory Affairs to join our team and help us develop and implement strategies to ensure compliance with all applicable regulations. You will have the opportunity to work with a diverse team of experts and have a direct impact on the success of our organization. If you are a motivated leader with a passion for regulatory affairs, this is the perfect role for you!

Overview:

Head of Regulatory Affairs is responsible for ensuring that the organization complies with all applicable laws, regulations, and standards. They are responsible for developing and implementing strategies to ensure compliance with all applicable regulations, as well as providing guidance and support to other departments. They also work closely with external stakeholders, such as government agencies, to ensure that the organization is in compliance with all applicable laws and regulations. How To Become an Head Of Regulatory Affairs jobs ? To become a Head of Regulatory Affairs, you will need a combination of education, experience, and specialized skills. A bachelor’s degree in a related field, such as law, business, or public policy, is typically required. Additionally, experience in a regulatory role is often preferred. Specialized skills such as knowledge of relevant laws and regulations, strong communication and negotiation skills, and the ability to work with external stakeholders are also important. Head Of Regulatory Affairs Skills requied For Your Resume And Career?
• Knowledge of relevant laws and regulations
• Strong communication and negotiation skills
• Ability to work with external stakeholders
• Analytical and problem-solving skills
• Ability to develop and implement strategies
• Project management skills
• Attention to detail
• Ability to work independently and as part of a team
Head Of Regulatory Affairs Knowledge For Your Resume And Career?
• Knowledge of relevant laws and regulations
• Knowledge of industry standards and best practices
• Knowledge of the organization’s products and services
• Knowledge of the organization’s policies and procedures
• Knowledge of the organization’s internal processes
• Knowledge of the organization’s external stakeholders
Head Of Regulatory Affairs Responsibilities For Your Resume And Career?
• Develop and implement strategies to ensure compliance with all applicable laws and regulations
• Monitor and review changes in relevant laws and regulations
• Provide guidance and support to other departments on regulatory matters
• Work closely with external stakeholders, such as government agencies, to ensure compliance
• Prepare and submit reports to relevant authorities
• Develop and maintain relationships with external stakeholders
• Manage and coordinate regulatory projects
• Monitor and review the organization’s compliance with applicable laws and regulations
Head Of Regulatory Affairs Experience For Your Resume And Career?
• Previous experience in a regulatory role
• Experience in developing and implementing strategies to ensure compliance
• Experience in working with external stakeholders
• Experience in preparing and submitting reports to relevant authorities
• Experience in managing and coordinating regulatory projects
Head Of Regulatory Affairs Qualifications For Your Resume And Career?
• Bachelor’s degree in a related field, such as law, business, or public policy
• Relevant certifications, such as Certified Regulatory Affairs Professional (CRAP)
• Relevant experience in a regulatory role
Head Of Regulatory Affairs Educations For Your Resume And Career?
• Bachelor’s degree in a related field, such as law, business, or public policy
• Relevant certifications, such as Certified Regulatory Affairs Professional (CRAP)
• Relevant experience in a regulatory role
What tools help Head Of Regulatory Affairs work better?
• Regulatory databases: Regulatory databases provide access to up-to-date information on laws and regulations.
• Compliance software: Compliance software helps organizations track and manage compliance requirements.
• Document management systems: Document management systems help organizations store and manage documents related to regulatory compliance.
• Project management software: Project management software helps organizations manage and track regulatory projects.
Good tips to help Head Of Regulatory Affairs do more effectively?
• Stay up to date on changes in laws and regulations: It is important to stay up to date on changes in laws and regulations to ensure compliance.
• Develop strong relationships with external stakeholders: Developing strong relationships with external stakeholders, such as government agencies, can help ensure compliance.
• Develop and implement strategies to ensure compliance: Developing and implementing strategies to ensure compliance with all applicable laws and regulations is essential.
• Monitor and review the organization’s compliance: Monitoring and reviewing the organization’s compliance with applicable laws and regulations is important to ensure compliance.
Common Head Of Regulatory Affairs interview questions?
• How have you ensured compliance with applicable laws and regulations in the past?
• What strategies have you implemented to ensure compliance with applicable laws and regulations?
• How do you stay up to date on changes in laws and regulations?
• What experience do you have working with external stakeholders?
• How do you manage and coordinate regulatory projects?