1,088 Regulatory Affairs Managers jobs in the United States

• This position administers, maintains, and generates reports for the Company's Annual Product Review.
• Supports administering and maintaining the Company's Documentation Change Control System for compliance documentation.
• Supports the development and implementation of regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives.
• Monitors regulatory activities (via searches of government internet web sites, review of USP supplements, Federal Register publications, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities.
• Assists in maintaining product and raw material master file documentation and databases.
• Adheres to all procedural requirements in the development of Master Records.
• Interfaces with Canadian and other international third parties to ensure Blistex regulatory compliance.
• Collaborates with R&D staff and provides support in the compilation and submission of records for new product launches and market-specific registrations.
• Uses Food and Drug Administration (FDA) monographs and other regulations to develop compliant Drug Facts Box information including active ingredients and concentrations, uses, warnings, directions, and inactive ingredients.
• Maintains facility licenses and drug listings.

• Bachelor's degree in chemistry, biology, or related scientific discipline with 2-3 years of applicable Quality Assurance environment experience, preferably in the cosmetics/pharmaceutical OTC industry; or 0-1 years of applicable Regulatory Affairs experience in the cosmetics/pharmaceutical OTC industry.
• Must demonstrate effective communication skills (both written and oral) for interactions with Quality colleagues, and colleagues from numerous functional areas.
• Computer literacy in a Windows environment (Word, Excel, and Outlook).
• Familiarity with FDA regulations and monograph system as they relate to OTC drug products.
• Working knowledge of Current Good Manufacturing Practices (cGMP) especially as related to the production and Quality lifecycle of an OTC drug.
• Strong organizational and analytical abilities and abilities to prepare detailed and accurate documentation.
• Strong discretion with confidential information.
• Ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management, and comply with Company policies.
• Ability to understand the importance and the elements of a good change control process and understand compliance product lifecycles.
• Solid understanding of technical requirements for all quality and regulatory documentation supporting batch production documents and their lifecycle.
• Ability to understand and interpret product regulatory requirements from FDA OTC monograph, US Pharmacopeia and/or others, local, state, federal and international regulatory agencies.

• Working understanding of the Company Stability program and its impact on product lifecycle.
• Firm understanding of the departmental compliance role and responsibilities.
• Strong ability to plan, organize, and complete concurrent tactical tasks and strategic departmental tasks independently.
• Clear understanding of the documents necessary to support a complete product master file and raw material master file.
• Willingness to perform and assume other duties and responsibilities, as may be required by the Senior Manager, Regulatory Affairs.

• Assist in collecting and reviewing supplier questionnaires, certifications, and food safety documentation (HACCP, GFSI).
• Maintain and update the Approved Supplier List (ASL) .
• Organize supplier files and ensure records remain accurate and up to date.

• Support the review of product labels, packaging, and marketing materials for compliance.
• Assist with ingredient statements, nutrition panels, and allergen information.
• Help manage label verification sheets and departmental records.

• Prepare and update product specifications, allergen statements, and regulatory documents .
• Respond to customer and internal inquiries with accurate product details.
• Assist with internal and external audits .
• Track certification renewals and regulatory deadlines.

• Bachelor's degree in Food Science, Food Technology, Nutrition, Biology, Chemistry , or related field.
• Up to 1 year of regulatory, quality, or compliance experience (internships and academic projects accepted).
• Basic knowledge of U.S. food regulations (FDA, USDA, FSMA) preferred (training provided).

• Strong organizational skills and attention to detail.
• Proficiency in Microsoft Office (Word, Excel, Outlook) .
• Excellent communication and teamwork abilities.

• Familiarity with food labeling requirements or food safety concepts.
• Exposure to GFSI-recognized schemes (SQF, BRC, FSSC 22000).
• Willingness to learn regulatory software (e.g., Nutritionist Pro, ESHA/Trustwell).
• Strong written communication and documentation skills.

Person responsible for regulatory compliance (EU MDR person responsible), who provides regulatory expertise and guidance for conformance to ISO 13485 and Medical Device Regulation 2017/745 (EU MDR), as well as compliance with applicable regulations such as those defined in the Medical Device Single Audit Program (MDSAP). Act as a subject matter expert to represent the site(s) quality initiatives and compliance objectives in the development of procedures, validations, and quality planning for the facility. Ensures quality systems are established and maintained in compliance with applicable local ordinances, state statutes, and Federal regulations, and other laws. Adheres to national and international regulations by performing the following duties.

The essential duties and responsibilities include the following. Other duties may be assigned.

• Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released.
• Monitors company compliance with ISO standards and applicable regulations.
• Maintains product technical documentation and the EU declaration of conformity up to date.
• Oversees customer complaint handling system including Medical Device Reporting (MDR) and Adverse Event Reporting.
• Oversees Document Control.
• Oversees Change Request Order (CRO) system.
• Oversees Corrective/Preventive Action (CAPA) system.
• Provides project direction, coaching, and monitoring for CAPA teams as required.
• Oversees CAPA system.
• Oversees Temporary Deviations System.
• Oversees Nonconformances System.
• Coordinates 510(k) or PMA submissions to send to the FDA.
• Oversees International registration of products, including coordinating with RTIs international sponsors regarding MDSAP related registrations.
• Maintains current registration status with applicable regulatory bodies such as the FDA and Health Canada.
• Assists with internal and supplier audit programs structured around ISO 13485, the Medical Device Regulations/EU MDR, and applicable MDSAP regulations including those from the FDA, Health Canada, ANVISA, and the TGA.
• Oversees subcontractor and internal audits and assists with vendor/supplier audits.
• Management Representative for ISO, FDA and other Regulatory Agencies, and third-party audits (FDA, ISO, etc.).
• Acts as point of contact and provides assistance during third party audits (FDA, ISO, etc.).
• Responsible for Post-Market Surveillance and reporting of serious incidents and field safety corrective action obligations.
• Acts as point of contact for the Authorized representative in the Union (EU).
• Serves as Independent Reviewer for product design review and participates as a member of other RTI work groups such as CIT, Kaizen, etc.
• Oversees RTI training system including but not limited to evaluation of training effectiveness and annual QMS training.
• Assists with Quality Plan preparation.
• Schedules and coordinates management review meeting and operations meetings, as well as various online training programs.
• Provides regulatory guidance on design and process validations, product labeling claims, advertising and promotional literature, and clinical studies.
• Provides direct supervision of the assigned team through ongoing leadership and guidance. Supervises day-to-day operations of employees.
• Assists with various projects as assigned by direct supervisor.
• Completes other duties as assigned.
• Identifies deadlines and implements methods to comply with responsibilities in a timely fashion.
• Ability to meet deadlines.
• Ability to get along with others, follow directions, and work well under stressful conditions.
• Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.

Direct Supervisor of Regulatory Affairs personnel.

College degree, certificate or other evidence of formal qualification awarded on completion of university degree, or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline. At least one year of professional experience in regulatory affairs, or in quality management systems relating to medical devices, or four years of professional experience in regulatory affairs or quality management systems relating to medical devices. Five or more years of experience in an ISO/FDA manufacturing environment CQA or RAC are preferred. Experience in computer/database software applications, preferably MS Word, MS Excel, MS Access, and Audit Master 3.

The intellectual skills described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Ability to speak, read and write English.
• Excellent customer relations and organizational skills.
• Excellent reporting, writing and presentation skills.
• Ability to communicate effectively with production and quality staff as well as all levels of management.
• Ability to multi-task.
• Ability to deal with varying degrees of stress induced by urgent business-related requirements.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• While performing the duties of this job, the employee is occasionally required to stand, walk, sit; use hands, reach, stoop and bend, climb stairs. The employee must occasionally lift and/or move up to 20 pounds. Intense use of vision is required for document/report inspection/analysis and observation of products and measuring equipment. Employee must be able and willing to travel, (travel is minimal).

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• The noise level in the work environment is usually moderate. Lighting is usually fluorescent. Heating/Air Conditioning/Ventilation is adjusted to accommodate production or laboratory environmental requirements. Employee may be subject to outside weather conditions when traveling on company business.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.
• Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
• Evaluate the risk of proposed regulatory strategies; may offer solutions.
• Reviews proposed labeling for compliance with applicable US and international regulations.
• Writes/manages the development of package inserts.
• Reviews and evaluates promotion and advertising material for compliance with applicable regulations.
• Reviews proposed product changes for impact on regulatory status of the product.
• Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions.
• Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions.
• Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products.
• Expected Areas of Competence.
• Demonstrated strong writing and communication skills.
• Strong attention to detail, ability to multi-task.
• Knowledge of overall business environment, the orthopedic industry, and the marketplace.
• bility to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products.
• bility to function well as a member of the team and build relationships between RA and other areas of the organization.
• ble to identify risk in Regulatory strategies.
• Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred.
• Basic computer skills, including Microsoft Office Suite.

• US bachelor's degree in life sciences, technical (engineering) or related field (or non-US equivalent).
• minimum of 3 years' experience in Regulatory Affairs
• dvanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred.
• Regulatory Affairs Certification (US or EU) preferred.
• combination of education and experience may be considered.

Regulatory Affairs Manager role at Katalyst CRO.

• Maintain full awareness of regulatory activities on assigned Project(s) and ensure that project deadlines and performance standards are established and met. Work with internal and external stakeholders to manage submission schedules.
• Compile high quality, right first-time submissions (Abbreviated New Drug Applications, New Drug Applications, amendments, supplements, annual reports, etc.). Draft ANDA/NDA modules for original applications, amendments, supplements, etc., for submission to FDA.
• Represent regulatory affairs in project team meetings and provide regulatory guidance to team members to meet scheduling timelines and resolve technical issues.
• Contribute to the preparation of controlled correspondences and meeting packages related to pre- and post-ANDA/IND/NDA meetings with FDA.
• Review technical reports and summary documents; evaluate change controls (chemistry, manufacturing and analytical controls) for appropriate content and formulate strategies with minimal guidance to ensure proper filing categories in accordance with FDA requirements.
• Act as point-of-contact with FDA for exchange of information, as required.
• Assess and remain current with new and changing guidance/regulations.
• Identify the need and implement improvements to existing department procedures and processes or SOPs, where applicable.
• Train and provide guidance to junior department members in above areas as required.

• Bachelor's degree required in a scientific discipline such as Chemistry, Biology, or Pharmacy. Graduate degree preferred.
• Minimum 7+ years' experience in the Pharmaceutical Industry.
• Minimum 5 years' previous experience in regulatory affairs.
• Minimum 3 years of regulatory experience in sterile dosage form.
• Experience with inhalation or transdermal dosage forms is a plus.
• Excellent attention to detail and organizational skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.

• Mid-Senior level

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• Pharmaceutical Manufacturing