Regulatory Affairs Manager/Sr Manager

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia.

This strategic role will report to the President. The successful candidate needs a thorough understanding of drug development process as well as hands-on experience managing the creation, review and finalization of regulatory submissions.

We are seeking an experienced, forward thinking hands-on leader. Project Management experience is essential. Regulatory experience in oncology or immunology is highly preferred. This is a great opportunity if you are a highly motivated team player, have the ability to plan proactively, work independently and have a strategic results oriented mindset.

In this role you will interact with all levels of company personnel based on role requirements. You'll serve as the primary point of contact for all regulatory responsibilities associated with assigned projects and represent regulatory function at cross function discussions. You'll liaise with vendor representatives, candidates, auditors and external agencies as required.

The primary responsibilities of this position include, but are not limited to, the following:

• Provide strategic regulatory input to all regulatory projects.
• Management, preparation, assembly of the Master Core Dossier and submissions of US/European:
• Clinical Trial Authorization Applications (CTAA) and amendments
• Country-level Informed Consent and other patient facing documentation
• Tracks, reports and files CTAA and amendment submissions/approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
• Proactively provides strategic direction to the client on regulatory specific issues and provides associated mitigation as required.
• Participates in the quality control (QC) steps involved for all the above.
• Serves as key regulatory liaison on behalf of Theradex. Liaison with other departments within Theradex, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.
• Maintains metrics on a monthly basis of all regulatory submissions made by Theradex. Strategic cross-functional interaction with a variety of departments to provide regulatory solutions to problems including the management of timelines to complete regulatory submissions on time.
• Responsible for providing assistance to perform effectively the planning, critical reviews and scientific writing of a number of regulatory activities such as IMPDs, DSURs, study protocols, IBs and patient information sheets in order to successfully obtain the regulatory approval.
• Validates and provides input into our clients’ regulatory development strategies, support our clients in preparing for and obtaining scientific advice from EU Competent Authorities and the EMA and prepare Orphan Drug Applications where required.
• Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.
• Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials.
• Supports Head of Department in business development activities including the preparation of client proposals and bid defense meetings.
• Provides regulatory training to other members of the team as required.
  
  

What You Need

Level of Education and Experience

• Bachelor’s degree required preferably in a life science field or equivalent.
• At least 5 years of industry experience in a regulatory role, preferably in oncology or immunology.
• Prior experience in a CRO/pharmaceutical environment required.
• Project Management Experience is essential.
  
  
  

Additional Requirements

• Ability to travel if needed based on project requirements or to travel to our Princeton, NJ headquarters for sponsor/audits etc.
  
  
  

Skills And Competencies

• Detailed Knowledge of ICH-GCP and local regulatory agency and ethics Committee regulations and requirements.
• The ability to stay informed about new guidelines and regulations as they are issued by regulatory authorities.
• Demonstrates ability to build and maintain effective relationships with others, establishing collaborative partnerships, trust and shared purpose
• Ability to anticipate problems relating to projects and to develop and implement solutions.
• Excellent interpersonal skills.
• Fluent knowledge of written and verbal English.
• Highly organized and result-oriented.
• Ability to work independently as well as in a team environment.
• Proficient knowledge of Microsoft Office packages including but not limited to Word and Excel.
  
  
  

What We Offer

We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more.

Theradex is an Equal Opportunity Employer.