Senior Specialist, Regulatory Affairs
Senior Specialist, Regulatory Affairs
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Job Description
Senior Regulatory Affairs Specialist will oversee the preparation and submission of regulatory dossiers ensuring compliance and timely approvals. This role involves strategic regulatory planning cross-functional collaboration and risk assessment across product lifecycle management quality management and pharmacovigilance. Senior Specialist will provide guidance on complex regulatory challenges drive process improvements and support audits ensuring adherence to local and international regulatory frameworks.
Roles and Responsibilities:
- Lead the preparation and submission of the regulatory dossier ensuring accuracy and efficiency
- Develop and execute regulatory strategies for new submissions variations renewals and post-approval commitments.
- Drive regulatory compliance through proactive monitoring and risk mitigation strategies.
- Mentor and provide oversight to junior regulatory specialists ensuring alignment with best practices.
- Actively involve in diligence of in house and partner products in every step of the product registration process until the final approval
- Review and approve artworks prescribing information and labelling for regulatory consistency.
- Engage with industry associations to stay ahead of regulatory changes and advocate for policy improvements.
- Lead the development and refinement of SOPs (Standard Operating Procedures) to optimize regulatory processes.
- Oversee quality management activities including audits risk assessments deviations and CAPA implementation.
- Manage pharmacovigilance operations including adverse event reporting and compliance.
- Manage and actively involve in execution of local bio equivalence studies (import license application LPI no. generation)
- Liaise with cross-functional teams to ensure seamless regulatory execution including medical commercial and supply chain teams.
- Represent the organization in regulatory discussions with authorities and external partners.
Qualifications :
Educational qualification: A Bachelor of Pharmacy or Industrial Pharmacy or Pharm D; Pharmacy professional license holder
Minimum work experience: 5-7 years of experience in regulatory affairs preferably with QA (Quality Assurance) and PV (Pharmacovigilance) experience
Skills & attributes:
- Good knowledge of local FDA guidelines.
- Experience with docubridge e-ctd software
- Proficiency in spoken and written English.
- Proficiency in using a computer and its applications specifically Google Applications and MS Excel.
- Excellent interpersonal and communication skills.
- Attention to detail and the ability to multi-task and meet strict deadlines.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
