Regulatory Affairs Operations Associate Jobs

Compile materials required in submissions, license renewal and annual registrations and maintains updated information about national/regional/global regulatory requirements.

Maintain and updates information about global regulatory requirements.

4+ years of Regulatory Affairs experience

Post-graduate and/or certification/ license may be required.

Review product labeling and marketing materials for accuracy and compliance with regulations.

Respond to customers and/or authorities requests/inquiries dealing with regulations and product compliance.

Experience with vendor and supplier management and engagement

Experience with contract management systems for legal agreements and contracts

May participate in continuous improvement activities related to role including supplier payment management, external agreement process, etc.

Bachelor's Degree in Business Administration, Economics, or related field preferred or a combination of education and experience.

Experience working in a fast-paced remote environment preferred as well as experience working with highly matrixed global organizations

A minimum of 3 years' experience in clinical regulatory affairs highly preferred.

Identify claims issues and lead/offer alternatives to comply with regulatory guidelines while supporting business needs.

Must be a solution oriented, self-starter with demonstrated problem solving skills.

Skilled in Excel and demonstrate accuracy with collecting and analyzing data.

Responsibilities include but are not limited to:

Lead regulatory functions and collaborate with cross-functional partners in support of the marketing review and documentation proofing process.

Regulatory Claim Subject Matter Expert (Marketing Support and Review)

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.

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)

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)

Regulatory experience in the cosmetic industry, with a particular focus of EU fragrance allergens is a plus.

IT Skills (Microsoft Office, SAP, etc.)

Analytical skills and understanding technical scientific information

Strong written and oral communication skills are required. Strong interpersonal skills are important for working in fast-paced and matrix driven environment

Gathering, generating, and managing technical fragrance information

Provide Regulatory guidance, and support, including but not limited to:

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.

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.

• 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)

7. Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements.

2. Exceptional planning/organizational skills and attention to detail.

3. Strong verbal and written communication skills.

1. 1 year of clinical research experience preferred.

1. Prepare regulatory documents for new study submissions to the IRB and sponsor.

Track the status of new submissions and inform clinical operations of relevant updates for study activation planning.

2+ years of experience in a clinical research environment.

Perform initial and subsequent IRB submissions.

Create and maintain the Investigator Site File for all studies awarded to Pharmaron CPC.

Generate all essential documents (i.e., Form FDA 1572, Financial Disclosure Forms, etc.) for submission to sponsor.

Report deviations/violations and Serious Adverse Events to the IRB.

Ensure IND safety reports are submitted to the PI and IRB for review.

Provide training on eCTD publishing processes and requirements related to the preparation, publishing and life-cycle management of electronic submissions.

Providing Electronic Document Management System (EDMS) user support for team members.

Electronic Document Management System (EDMS)

Representing Reed Tech and address the client’s business requirements and needs.

Experience with DocuBridge and Veeva Vault RIM preferred.

Excellent Word and Adobe Acrobat skills required.

Excellent project management skills. Must be incredibly efficient while also exercising judgment in allocating limited resources.

1-2 years experience in the energy sector preferred, with some working knowledge of the wholesale markets.

Master our business by working across the organization (Operations, Energy Markets, Engineering) and use that knowledge in advocacy.

Excellent written and verbal communication skills, effectively distilling complex ideas. Comfortable with basic data analysis.

Graduate degree (e.g., J.D. or Masters Degree) strongly preferred, or equivalent experience, with 0-2 years of post-degree work experience.

Work with cross-functional teams, especially Energy Markets, to develop these communications.

Project management and process improvement experience

Proficiency in designing and improving workflows, and demonstrative project management experience.

5+ years of healthcare industry regulatory analysis experience, in the health plan/managed care space.

Project manage the internal tracking and monitoring of Regulatory Operations team deliverables related to our Legislative processes.

A bachelor's degree in a legal, healthcare-related or humanities field, or 4 years commensurate experience.

Be the EOC SME for the regulatory operations ecosystem and current strengths, weaknesses, and gaps within important region(s)

Be able to provide support to regulatory management and project teams and implement regulatory strategy while delivering documentation on time.

Maintain and manage databases containing regulatory information, submissions, and correspondence.

BS in life sciences with a minimum of 3 years of experience in Regulatory Affairs

Experience submitting IND filings utilizing eCTD formatted submissions highly desirable.

Independently plan daily work to complete time-sensitive assignments while following general instructions for project completion.

Review documents necessary for the regulatory site documentation related to the shipment of drug products to clinical sites.

Experience in patient advocacy, community engagement, and issues management

Publications management: alignment/tracking of regional plans, management/tracking of publication reviews and approvals, understanding of good publication practice

Tracking/management on the development of core decks, lexicons, scientific communication platforms, etc

Ability to interact with senior management, academic experts and patient advocates appropriately, with confidence and ease

Assist with other duties related to the Medical Affairs Operations function qualifications

Prior experience in communications or medical affairs is highly desired

• Experience with submission work in VaultRim

• Experience with RA compliance reports including (NDA, BLA, ODD, DSUR, PBRER annual reports)

Qualified applicants will have the following expertise:

Ability to use project management tools, including Smartsheet & SharePoint

Advanced MS Office (Word, PowerPoint, Excel) skills

Strong communication and collaboration skills

Demonstrated ability to manage multiple work streams

Prior experience in a compliance or regulatory function preferred

Typically, a minimum of 1-3 years of relevant experience. May have a degree or equivalent

Track and manage documentation for the Regulatory Project Plans including agency consultation,

Support variety registration when applicable and verify data needs and generation. Manage filing

Support Regulatory Intelligence activities and tracking evolution of data requirements and

Monitor Regulatory competitor activities and access to information where available. Manage the

Solid experience in biological sciences, preferably agricultural sciences, or related disciplines;

3-5 years of work experience in agricultural or microbial biotechnology