Senior Regulatory Affairs Specialist

ComplianceComplianceFull TimeRemoteTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

Texas

Posted

88 days ago

Salary

Not specified

Bachelor Degree3 yrs expEnglishAssembly

Job Description

• Manage preparation, assembly, publishing, and submissions of US and Canadian regulatory applications • Support key regulatory affairs consultants with expertise in regulatory strategy and processes • Draft and manage regulatory submissions and drug listing submissions • Coordinate regulatory fee payments on behalf of clients • Maintain knowledge of changing regulatory requirements • Liaise with regulatory authorities on behalf of clients • Build and maintain working relationships with clients • Conduct issue resolution and communicate with clients • Perform document management tasks • Maintain familiarity with global regulatory submission standards

Job Requirements

  • Bachelor’s Degree
  • 3-5 years’ experience in Regulatory Affairs or equivalent
  • Experience working in the pharmaceutical industry
  • Understanding of FDA and Canadian Regulatory Affairs procedures
  • Ability to prioritize and drive multiple projects
  • Ability to train and support junior/new colleagues
  • Previous hands-on experience with regulatory submissions
  • Ability to maintain confidentiality and respond to client needs
  • Outstanding organization, analytical, and problem-solving skills
  • Excellent written, verbal and presentation communication skills

Benefits

  • Health insurance
  • 401(k) matching
  • Paid parental leave
  • Adoption assistance
  • Infertility coverage
  • Family building support
  • Backup dependent care
  • Paid caregiver leave
  • Behavioral health solutions
  • Professional development resources
  • Mentorship programs
  • Volunteer activities

Related Categories

Related Job Pages

More Compliance Jobs

IT Compliance, GRC Analyst

LifeMD

LifeMD (Nasdaq: LFMD) is a rapidly growing direct-to-consumer telemedicine company.

Compliance88 days ago
Full TimeRemoteTeam 201-500H1B Sponsor

IT Compliance Analyst supporting SOX and HIPAA programs at LifeMD

SDLC
California + 1 moreAll locations: California, New York

Compliance Manager

Keyfactor

Identity-first security for every machine.

Compliance88 days ago
Full TimeRemoteTeam 201-500Since 2014H1B Sponsor

Manager overseeing compliance efforts at Keyfactor

Cyber Security
United States
Full TimeRemote

This position is for a Regulatory Affairs Expert in Food & Food Ingredients. The successful Regulatory Affairs Expert candidate will work with internal/cross-functional team members, customers, development teams, and stakeholders throughout the organization to ensure client satis...

Regulatory AffairsEU Food LawFood LabelingUSDA RegulationsProduct ComplianceCross-functional CollaborationClient Relationship ManagementJIRA
United States + 180 moreAll locations: United States, Canada, Brazil, Colombia, Argentina, Chile, Venezuela, Bolivarian Republic Of, Bolivia, Plurinational State Of, Ecuador, French Guiana, Guyana, Paraguay, Peru, Suriname, Uruguay, Mexico, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Dominican Republic, Puerto Rico, Bahamas, Guadeloupe, Haiti, Jamaica, Martinique, Montserrat, United Kingdom, Germany, France, Estonia, Portugal, Hungary, Poland, Ukraine, Romania, Bulgaria, Czech Republic, Slovakia, Belarus, Moldova, Republic Of, Sweden, Greece, Belgium, Italy, Ireland, Switzerland, Netherlands, Finland, Malta, Denmark, Lithuania, Croatia, Spain, Austria, Bosnia And Herzegovina, Iceland, Luxembourg, Macedonia, The Former Yugoslav Republic Of, Montenegro, Norway, Serbia, Slovenia, Albania, Cyprus, Latvia, Monaco, South Africa, Egypt, Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Congo, Côte D'ivoire, Congo, The Democratic Republic Of The, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-bissau, Kenya, Lesotho, Liberia, Libyan Arab Jamahiriya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mayotte, Morocco, Mozambique, Namibia, Niger, Nigeria, Réunion, Rwanda, Senegal, Seychelles, Sierra Leone, Somalia, Sudan, Swaziland, Tanzania, United Republic Of, Togo, Tunisia, Uganda, Zambia, Zimbabwe, Georgia, Turkey, Israel, United Arab Emirates, Armenia, Azerbaijan, Bahrain, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Palestinian Territory, Occupied, Yemen, India, Japan, Philippines, Pakistan, Thailand, Singapore, Viet Nam, Taiwan, Province Of China, Indonesia, Cambodia, Lao People's Democratic Republic, Malaysia, Myanmar, Korea, Republic Of, China, Afghanistan, Bangladesh, Bhutan, Kazakhstan, Kyrgyzstan, Maldives, Mongolia, Nepal, Sri Lanka, Tajikistan, Turkmenistan, Uzbekistan, Australia, Papua New Guinea, Kiribati, Palau, French Polynesia, Tuvalu, New Zealand

Head of Global Compliance

The L Suite (TechGC)

TechGC is now part of The L Suite

Compliance89 days ago
Full TimeRemoteTeam 51-200Since 2015H1B No Sponsor

Senior compliance leader architecting global compliance functions for Cognite

United States
$275K - $325K / year