Senior Regulatory Affairs Associate managing EU CTA strategy, submissions, and compliance for Parexel’s global clinical research services. Coordinating health authorities, CROs, and cross - functional teams.
About the role
- Director of Regulatory Affairs advising pharmaceutical and biotech clients on FDA development strategies. Preparing IND/NDA/BLA documentation and leading Health Authority interactions.
Responsibilities
- Provide strategic and operational regulatory consulting for client companies
- Advise clients strategically, focusing on early development through NDA/BLA
- Independently prepare regulatory documentation, including US IND, NDA/BLA modules, ODD, Fast Track and other designations, and FDA advice requests
- Interact scientifically with internal cross-functional teams
- Serve as a client-facing and agency point of contact
- Interact with clients and FDA and lead interactions with Health Authorities
- Support internal business development and marketing activities
Requirements
- Bachelor’s degree in science, toxicology, pharmacology, engineering or related field
- Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials
- 10 years of relevant experience working directly for a CRO/ Pharmaceutical Company
- Minimum 5 years of experience leading regulatory development projects
- Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines
- Knowledge of medical terminology, clinical trials, and clinical research
- Excellent written and oral communication skills, including grammatical and technical writing skills
- Familiarity with moderately complex study designs and regulatory requirements for Phase I-IV clinical trials
- In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies
- Demonstrated technical and supervisory leadership of staff
- Skilled in Microsoft Word and Microsoft Excel, with ability to learn new applications
- Excellent interpersonal, communication, and organizational skills
- Ability to work independently and in a team environment
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus
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