COD Research, a leading name in the clinical and contract research industry, specializes in delivering high-quality, compliant, and innovative solutions for regulatory submissions across global markets. Renowned for its expertise in regulated, semi-regulated, and ROW markets, COD Research is committed to excellence and precision. The company has a strong presence in Ahmedabad and is well-regarded for its employee-friendly policies and professional growth opportunities.
Key Responsibilities of a Regulatory Affairs Specialist
As a Regulatory Affairs Specialist, your primary responsibility will be to ensure regulatory compliance and successful submission of high-quality documentation for various markets, including the US, EU, and ROW. Key tasks include:
- Document Preparation and Management:
- Development of regulatory documents like CTAs, IND/IMPD, MAA/BLA, and response documents.
- Compilation of dossiers for regulated and semi-regulated markets.
- eCTD Publishing Support:
- Support the deployment of tools for electronic Common Technical Document (eCTD) publishing.
- Perform dossier gap analysis based on updated country-specific guidelines.
- Strategic CMC Oversight:
- Lead and support Chemistry, Manufacturing, and Controls (CMC) aspects of dossiers.
- Evaluate changes in CMC documentation and strategize filing categories.
- Provide due diligence support for CMC strategies, especially for complex injectable products.
- Stakeholder Coordination:
- Collaborate with internal and external stakeholders to ensure timely and high-quality submissions.
- Regulatory Meetings and Query Resolution:
- Represent the organization in meetings with health authorities.
- Address and resolve queries related to dossier assessments.
Qualifications for the Role
To be successful in this position, candidates must meet the following criteria:
- Educational Background: A graduate or postgraduate degree in Pharmacy is mandatory.
- Experience: A minimum of 3-6 years of experience in Regulatory Affairs, with a preference for expertise in the US and EU markets.
- Preferred Skills:
- Knowledge of CMC requirements for solid dosage forms and complex injectables.
- Familiarity with eCTD publishing and country-specific guidelines.
Skills Required
- Strong analytical and organizational abilities.
- Exceptional communication and interpersonal skills.
- Expertise in regulatory guidelines and submission standards.
- Ability to manage multiple projects and meet tight deadlines.
- Proficiency in addressing regulatory queries and performing gap analyses.
