Regulatory Affairs Manager (India) – IQVIA Biotech
Primary Location: Bangalore, India
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Directs the performance of the regulatory affairs staff. Develops project timelines, develops strategic goals with staff, and provides guidance as needed for completion of tasks. Assesses performance and recommends salary adjustments.
- Manages/oversees assembly and submission of applications to US or EU competent authorities.
- Maintains effective communication with customer and project team through oral and written correspondence, regulatory status reports as defined. Reports progress, challenges, issues, actions and support required.
- Directs the process for the selection of central IRBs where applicable. Manage multiple site activation process and documentation. Attends project meetings with cross functional department leads to provide regulatory affairs strategy.
- Directs review and submission of essential regulatory documents for investigational product release and site activation.
- Directs the development of Regulatory Document Management Plans (RDMP) and works to incorporate such plans with the study start up plan and Monitoring Plan in accordance with ICH/GCP and assures compliance.
- Designs, develops, and updates Standard Operating Procedures for all US or EU regulatory affairs functions.
- Develops budgets and is accountable for the profit/loss for regulatory affairs activities of each project and the overall performance of the regulatory affairs team.
- Develops budgets for the regulatory affairs component of proposals in conjunction with Global Head, Regulatory Affairs.
- Keeps abreast of, interprets and communicates applicable regulatory agency regulations and statutes with internal departments and ensures IQVIA Biotech compliance.
- Assures that regulatory affairs functions interface effectively with all other key operating departments within IQVIA Biotech.
- Works with Human Resources in recruiting and hiring qualified regulatory staff for IQVIA Biotech projects.
- Ensures training for the regulatory affairs staff. Selects training curriculum for the staff.
- Reviews and approves reports and manuscripts, as necessary.
- Maintains current knowledge of FDA and/or EU regulations, and GCP and ICH Guidelines for clinical research.
- Participates in business development activities to grow IQVIA Biotech business.
KNOWLEDGE, SKILLS AND ABILITIES:
- Demonstrated knowledge of electronic data management operations.
- Demonstrated knowledge of quality assurance related to study startup and regulatory document collection and review.
- Demonstrated ability to form strong working relationships across functional boundaries.
- Demonstrated ability to motivate, lead, and grow a regulatory affairs team.
- Extensive demonstrated experience directing and supervising staff.
- Experience in medicinal product and medical device regulatory affairs.
- Experience with pharmaceutical product development.
- Excellent knowledge of GCP/ICH guidelines for conducting clinical research.
- Excellent written and verbal communication skills.
- Excellent negotiation skills.
- Exceptional ability to conceptualize, develop and manage timelines.
- Demonstrated knowledge of resources required to permit protocol implementation.
- Considerable ability to develop and maintain productive relationships with colleagues and other research organizations.
- Ability and willingness to travel internationally.
CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Ability to travel internationally
- Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
- BS in a health-related field with at least 3-5 years of regulatory experience or five years of demonstrated clinical trials experience; or appropriate BA/BS Degree in life sciences (i.e., nursing, pharmacy, pre-medicine, clinical research etc.) Within the total years of experience, at least three (3) years of management experience in a clinical research position is preferred.
- Pharmaceutical clinical research experience and electronic data management experience are required.
- Excellent demonstrated knowledge of issues affecting regulatory affairs for clinical trials are required. Excellent written and verbal communication skills are required.
- Documented continuing education in regulatory affairs or Regulatory Affairs Certification preferred