Regulatory Affairs Internship Jobs

Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.

Reports to labeling management in Regulatory Operations and Innovation.

Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).

May be responsible for managing projects, processes, or programs with manager oversight.

Experience and/or Familiarity with Structured Content is preferred

Excellent verbal and written communication and skills.

Interpret and apply regulatory requirements

Regulatory history, guidelines, policies, standards, practices, requirements and precedents

Principles and requirements of applicable product laws

Principles and requirements of promotion, advertising and labeling

Has broad knowledge of various technical alternatives and their potential impact on the business

Use in-depth knowledge of business functions and cross group dependencies/ relationships

Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)

Proficient knowledge of domestic and international standards

Experience in supporting international registrations and/or clinical investigations.

Experience with Software Medical Devices strongly preferred.

Proficient computer skills in Microsoft Office Suite

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Solid knowledge and understanding of global regulatory requirements for new products or product changes.

Good written and verbal communication skills and interpersonal relationship skills

Good problem-solving, organizational, analytical and critical thinking skills

Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

Solid knowledge of new product development systems

Ability to manage competing priorities in a fast paced environment

Effectively monitor and track information and requirement changes

Maintain compliance with regulatory requirements and regulatory databases for generic drugs for the US market.

Adhere to all health, safety & environmental (HSE) requirements in support of departmental and site HSE goals

Excellent oral and written communication skills

Pharmaceutical or generic drug experience in a regulatory capacity

Lab experience and familiarity with Abbreviated New Drug Application (ANDA) and/or Electronic Common Technical Document (eCTD)

Manage regulatory release authorization process

Experience working in an FDA regulated company for medical device or pharma is preferred

2+ years’ experience in quality assurance or regulatory affairs is preferred

Previous experience in a position that required multi-department interactions

Able to manage time effectively

Develop and compile documentation in support of new registrations

Deep knowledge of the relevant Regulatory requirements

Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths

8+ years relevant experience within the Regulatory Affairs discipline

Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources.

Proven analytical skill and technical/scientific competence.

Strong initiation and organizational skills

Assist in keeping company informed of regulatory requirements in the International Regions.

Host meetings with relevant R&D, Quality, Manufacturing facility, Marketing and Cross Functional Teams as needed to support global registration requirements.

Bachelor's degree with 2 years of regulatory affairs experience

An advanced degree with 0 years of regulatory affairs experience

3+ years of medical device regulatory affairs experience

Experience with international submissions and experience with the FDA

-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.

Skilled in the use of clinical trials and electronic document management systems

Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.

Assist with sponsor monitoring visits remotely and onsite as needed.

Perform other responsibilities as assigned.

Bachelor’s Degree in a related field or equivalent experience

Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)

Experience with Microsoft Access Preferred

Strong knowledge of Microsoft Excel, Word, Outlook, and Adobe Acrobat software.

Location: Remote, PA, United States of America

Liaise with the distributor, service, and engineering departments in acquiring relevant information for complaint investigations.

Compile complaint investigation information for final RAE review and approval.

Provide administrative support during product recall notifications, advisory reports, and incident reports.

Communicate submission requirements to product development and process improvement teams.

Develop detailed strategies and perform activities necessary to secure domestic and foreign regulatory clearance, approval, and registration of products.

Maintain annual facility registrations and product listings as appropriate.

Develop competitive regulatory strategies and execute on filing submissions to regulatory authorities and ensure the maintenance of regulatory files.

Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites.

Requires Bachelors in Pharmacy, Regulatory Affairs, any Scientific Degree, or related.

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.

Perform other related duties and responsibilities, on occasion, as assigned.

Excellent communication skills and attention to detail.

Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneously.

Must be able to write clear, understandable technical documentation, i.e. regulatory documentation or scientific presentations. Excellent oral presentation skills.

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

· Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers

· Knowledge ofregulatoryguidelines and relevant applications.

· Demonstrate effective leadership, communication, interpersonal skills, and soft skills.

Inviting applications for the role of CMC 3 Manager-RegulatoryAffairs !

Qualifications we seek in you!

• Proven and relevantregulatoryaffairs experience in pharmaceutical, vaccine, or biological products; or related fields

Extensive project management skills with the ability to work under deadlines, handle multiple priorities simultaneously, and work across multi-disciplinary teams.

3-7 years of Regulatory Affairs experience in the medical device or other area of life science industry.

FDA regulatory submission experience (Pre-Submission, 510Ks, De Novo, IDEs) and international submission experience a plus.

Do want the flexibility to work from home, with only being in the office 1-2 days/week?

Devise and execute with regulatory pathways and strategies, premarket FDA, and international regulatory submissions.

Serve as point person for external audits by regulatory and third party auditors.

Strong organization and time management skills

Bachelor’s Degree with 2 years of regulatory affairs experience

An advanced degree with 0 years of regulatory affairs experience

2+ years of medical device regulatory affairs experience

Ability to effectively manage multiple projects and priorities

Excellent written and verbal communications skills

Other Skills and Abilities: Knowledge and understanding of US, EU MDR and international medical device regulations.

Certificates, Licenses, Registrations: RAC certification is preferred.

Regulatory Experience: Minimum 4 years (Required).

510(k)/Technical File Experience: Minimum 4 years (Required).

Responsible for development of product launch strategy, including documenting testing requirements, submission pathways, and anticipated approval/clearance timelines for defined target markets.

Researching and consolidating regulatory requirements to enable future development of regulatory strategies for all regions.

Knowledge of and experience with the rulemaking process set out in the North Carolina Administrative Procedure Act

Ability to work effectively with outside attorneys, senior management, and staff

2 or more years related progressively responsible professional legal experience

Strong analytical, problem-solving, and decision-making capabilities. Must be detail and process oriented

Strong communication skills, which include exceptional presentation, written and verbal communication skills, and a strong background in technical writing

Provide support to the Director of Regulatory and Legal Affairs and North Carolina Commission for Public Health in administrative rulemaking

Professional experience in regulatory project management/program management and regulatory agency interactions.

Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

Proved work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.

Professional experience in Regulatory Affairs / Quality Assurance.

Experience with Software as a Medical Device (SaMD), cybersecurity, and other non-device software products.

Communicate to the Operations Manager, Director of Quality, or other Senior Management as appropriate any potential issue.

An experienced formulation and applications team

Prior experience working with documentation pertaining to nutritional supplements and ingredients

Good analytical problem-solving skills. Meticulous with follow-up

Good communication skills. Able to give clear directions to others.

Quality Assurance, Compliance, Labelling, Documentation, and Regulatory Requirements