Cmc Regulatory Affairs Jobs

-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.

· 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

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

Lead and manage multiple and concurrent drug substance projects, with responsibilities including:

Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.

Good organizational skills and the ability to manage multiple competing priorities.

Lead and manage formulation development, which may entail one or more of

Experience working, collaborating with, and managing CDMOs.

Good knowledge of formulation options and troubleshooting

Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance

Communicates issues to management through project management tracking and issue briefings.

Minimum of 3 years’ experience

Ability to manage and track broad and strategic projects.

Responsible for effective communication of regulatory requirements to project teams and internal customers.

Position is highly visible to internal and external stakeholders.

BS in a quantitative or scientific discipline with 4+ years of relevant data science/analytics experience in the pharmaceutical industry

Experienced with computer languages (R, Python, SQL, etc.) and statistical software packages (JMP, Statistica, Minitab, etc.) to manipulate and analyze data

Experienced with business informatics tools (e.g. Tableau, Power BI, Spotfire)

Prior experience working in a GMP environment and understanding of bioprocessing unit operations is a must

Drive and support data pipeline initiatives

Engage with the delivery of new process analytics tools cross-functionally

Experience with prep and filing of the following applications: FDA IND/ANDA/NDA/BLA applications and maintenance submissions

Experience with leading cross-functional teams

As the roles can range, it would be ideal to have experience with the following:

5+ years in Regulatory Affairs (ex: generics, prescription drugs and biologics)

May require up to 10% travel

This would be a contract role, and they are open to either full-time or part-time capacity.

Project management experience with excellent interpersonal, presentation and communication skills.

Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 

Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.

One or more years of experience fulfilling a key role in major filing activities.

Experienced in supervising and training junior staff and the ability to motivate and lead others.

Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.

8 to 12 years’ experience working in a regulated, life science environment with Strong project management interpersonal skills.

Experienced in defining Organizational Strategy, Process and Change Management, KPIs and Metrics, Project Management, Resource Forecasting.

Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines.

Responsible for Product lifecycle management & plan for global regulatory filings and assessments as required by the individual project.

Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.

Should have demonstrated ability to manage the product life cycle submissions in key regulated markets like US, Canada, UK & EU.

• Serves system administrator for the client's US Regulatory electronic document management system

Location: Deerfield IL Or 100% Remote

Job Title: Publishers (US Submissions)

Pay Range: $25.00/hr to $30.00/hr on W2

• He/she will serve as the primary publisher of US Regulatory submissions (Drug and Device)

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

Knowledge or experience with regulatory requirements in other regions and familiarity with GMP regulations is a plus.

In-depth knowledge of ICH requirements and regulatory requirements in the US/EU.

Proficiency in authoring complex technical documents, including CTD M2 and M3 sections, and life cycle management.

8+ years of experience in regulatory CMC within the pharmaceutical or biopharmaceutical industry.

Excellent oral and written communication skills are essential.

Detail-oriented, self-motivated, and comfortable handling broad responsibilities in an entrepreneurial, fast-paced environment.

80% employer-paid MEDICAL HMO plan

80% employer-paid DENTAL PPO plan

We are in works to add 100% employer-paid Basic Life/AD&D + ST Disability

We will eventually also add a Medical PPO plan

Maintains current knowledge of regulations and guidelines (FDA, ICH, and others as required).

5-10 years experience in regulatory CMC

Coordinate and lead the task of drafting responses to CMC-related questions from FDA or foreign health authorities.

Work with functional groups to provide timely responses to CMC questions from regulatory authorities.

Coordinates activities for meetings with FDA and other regulatory authorities.

Coordinates with cross-functional teams to define contributions to submissions.

Solid experience of software and SaMD regulatory requirements for medical devices

Familiarity with software development life cycle methodologies, risk management, and QMS.

Provide guidance and support to cross-functional teams in the interpretation and implementation of software regulatory requirements, standards, and guidelines

Remote/Hybrid with site visits to Boston, MA

Medical Device & IVD Experience

Liaise directly with FDA to ensure successful 510K and product clearance

Support regulatory change management by performing key ingredient searches in the database to evaluate the impact of regulatory change

Supportive management invested in your success

2-3 years of experience in regulatory affairs at a food, beverage, or consumer product company

Experience in International regulatory, Dragonfly/yellowfin, MS Office

What are your daily job duties:

Screen and approve new ingredients per the aligned service level agreement to ensure data accuracy