Senior Executive/Specialist - Regulatory Submission
- Employer
- ClinChoice
- Location
- Bengaluru, India
- Salary
- Competitive
- Start date
- 28 Oct 2024
- Closing date
- 26 Nov 2024
View more categoriesView less categories
- Discipline
- Regulatory Affairs, Regulatory Writing
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
at ClinChoice (View all jobs)
Bengaluru
Position Overview:
We are seeking a detail-oriented and highly motivated Regulatory Submission Specialist to join our regulatory team. The Regulatory Submission Specialist will play a critical role in managing and overseeing the preparation, submission, and tracking of regulatory documents to global health authorities, including the FDA, EMA, and other regulatory bodies. This position offers the opportunity to work in a dynamic, fast-paced environment and contribute to the successful delivery of regulatory submissions for clinical trials and product approvals.
Key Responsibilities:
- Regulatory Documentation Preparation:
- Coordinate, compile, and prepare high-quality regulatory submissions including INDs, NDAs, BLAs, CTAs, MAAs, and amendments in compliance with regulatory requirements.
- Ensure that all submission components (e.g., modules, reports, protocols) are accurate, complete, and prepared according to applicable guidelines and templates.
- Submission Management:
- Manage timelines and track progress of submissions to ensure timely delivery to regulatory authorities.
- Serve as a point of contact with internal teams (clinical, medical writing, data management) and external partners (clients, regulatory authorities) to facilitate submission activities.
- Regulatory Intelligence & Compliance:
- Stay current with global regulatory requirements, guidelines, and best practices to ensure submission processes comply with local and international standards.
- Support regulatory strategy discussions by providing insights on submission pathways and requirements for new products or clinical trials.
- Quality Control:
- Perform detailed quality checks of regulatory documents to ensure accuracy, completeness, and compliance.
- Identify and resolve any inconsistencies or discrepancies in submission content or format.
- Systems & Tools:
- Use electronic submission systems (e.g., CTIS, IRAS, CESP) to prepare and submit regulatory dossiers.
- Maintain regulatory tracking tools and databases to monitor submission status and compliance deadlines.
Required Qualifications:
- Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field. Advanced degree preferred.
- Experience:
- 3-6 years of experience in regulatory submissions within the pharmaceutical, biotech, or CRO industry.
- Strong knowledge of FDA, EMA, and other global regulatory requirements and submission formats (e.g., eCTD).
- Technical Skills:
- Proficiency in electronic submission platforms and regulatory document management systems.
- Strong command of Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat.
- Communication & Collaboration:
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively with cross-functional teams.
- Attention to Detail:
- High level of accuracy in reviewing and preparing complex regulatory documents.
Preferred Qualifications:
- Familiarity with regulatory requirements for medical devices, biologics or NCEs.
Company
ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.
We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
GB
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