Regulatory Affairs Specialist

0-2 years

Not Disclosed

Ahmedabad Bangalore Delhi Hyderabad Mumbai

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here is a general outline for the role of a Regulatory Affairs Specialist:

Job Title: Regulatory Affairs Specialist

Location: Varies (Dependent on Employer)
Employment Type: Full-Time/Part-Time
Shift Timing: Varies (Standard Business Hours)
Job Summary:
The Regulatory Affairs Specialist is responsible for ensuring that products comply with all regulations and laws required by government agencies for market approval. This includes gathering, compiling, and reviewing documents necessary for regulatory submissions, maintaining regulatory documentation, and communicating with regulatory authorities. The role often involves working with cross-functional teams to ensure regulatory requirements are met during the product development process and throughout its lifecycle.

Key Responsibilities:

Regulatory Submissions:
- Prepare and submit regulatory filings to government agencies (e.g., FDA, EMA, etc.) for product approvals, renewals, and updates.
- Ensure timely and accurate submission of regulatory documents for compliance with national and international laws.
Documentation and Compliance:
- Review and update regulatory documentation to ensure compliance with industry standards, regulations, and best practices.
- Monitor the regulatory status of products to maintain compliance and manage risk.
Cross-Functional Collaboration:
- Collaborate with R&D, manufacturing, quality control, and marketing teams to ensure that products meet regulatory standards throughout development.
- Provide guidance on regulatory requirements during the product development cycle.
Communication with Regulatory Authorities:
- Act as the primary point of contact for regulatory agencies.
- Address inquiries from regulatory bodies and manage responses to inspection findings.
Market Surveillance and Updates:
- Keep up to date with changes in regulations and ensure products comply with new or updated guidelines.
- Monitor post-market surveillance activities and maintain product registrations.
Regulatory Strategy:
- Assist in the development of regulatory strategies for product approvals and market entry.
- Conduct regulatory intelligence to inform strategic decisions for product development.

Qualifications:

Education: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related field (Master’s or higher preferred).
Experience: 2-5 years of experience in regulatory affairs, particularly in the medical device, pharmaceutical, or biotech industries.
Skills:
- Strong understanding of regulatory guidelines (FDA, EMA, ICH, etc.).
- Proficient in regulatory submission processes and documentation.
- Excellent communication skills, both written and verbal.
- Attention to detail and organizational skills.
- Familiarity with project management software and regulatory affairs tools.

Additional Qualifications:

Certifications such as Regulatory Affairs Certification (RAC) may be beneficial.
Experience with international regulatory affairs and understanding global market requirements is an advantage.

If you're interested in the regulatory landscape and ensuring products are compliant with the highest standards, this could be a great fit for you!

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Regulatory Affairs Specialist

Job Description

Job Title: Regulatory Affairs Specialist

Key Responsibilities:

Qualifications:

Additional Qualifications:

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