Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Regulatory Affairs Specialist managing compliance and regulatory documentation for pharmaceutical raw materials. Collaborating with sales and support teams in a lead distributor of chemicals and ingredients.
Responsibilities
- Support the regional Pharma division Sales Team on regulatory, legal, compliance, quality, and product safety topics related to raw material supply into the pharmaceutical industry.
- Complete technical and regulatory documentation and respond to customer information requests (e.g., questionnaires, supply chain agreements, QAA’s & TA’s).
- Source information internally and from suppliers to satisfy customer requests.
- Report and document customer requests via KPIs.
- Manage Process Change Control Notifications.
- Collaborate with commercial and value-added services teams on regulatory topics for customer projects.
- Work with QHSE & supply chain teams to ensure regulatory compliance and support implementation of new standards (IPEC GMP/GDP, EXCiPACT, GDP).
- Participate in EMEA Pharma Regulatory team projects.
- Create and manage product regulatory information in a standardised format.
- Provide training on regulatory topics to commercial and supply chain teams.
- Undertake any other tasks within capability to support the commercial success of the Pharma business unit.
Requirements
- Degree or significant experience in life sciences.
- Knowledge of pharmaceutical industry requirements and regulations on APIs, excipients, biopharma, and traditional pharma raw materials.
- Understanding of European National Competent Authority requirements for distribution of APIs, excipients, and raw materials.
- Fluent in English (spoken and written).
- Strong collaboration, communication, and interpersonal skills with the ability to work proactively across all levels and functions.
- Experience working with regulatory documentation (desirable).
- Knowledge of GxP requirements in Pharma and/or Biopharma (desirable).
Benefits
- Competitive salary and annual bonus scheme.
- 25 days holiday plus bank holidays.
- Pension plan and life assurance.
- Access to learning and development opportunities.
- Employee assistance programme and wellbeing initiatives.
- Career progression within a global organisation.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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