Manager - 1

2+ years

Not Disclosed

Vadodara

10 Dec. 25, 2024

Job Description

Job Type: Full Time Education: M. Pharm 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

Job Title: Regulatory Affairs Manager - India Market

Location: Sun Pharmaceuticals (or other company, based on your requirements)
Department: Regulatory Affairs
Industry: Pharmaceutical

Job Summary:

The Regulatory Affairs Manager will be responsible for the evaluation, preparation, and submission of regulatory documents for drugs and medical devices in India. This role involves ensuring compliance with the regulatory requirements for product registration, importation, and manufacturing permissions with the Drug Controller General of India (DCGI) and other relevant authorities.

Key Responsibilities:

Regulatory Strategy Evaluation:
- Evaluate regulatory strategies for products to be registered in India, ensuring compliance with local regulations.
- Develop and execute strategies for obtaining domestic manufacturing and marketing permissions.
Regulatory Submissions:
- Evaluate and submit applications for domestic manufacturing and marketing permissions via the online portal for approval from DCGI.
- Evaluate and submit applications for import registration/import licenses for drugs and medical devices.
Document Coordination:
- Review and evaluate the documents that need to be submitted with the applications, coordinating with the relevant teams to finalize them.
- Ensure that all documents are complete, accurate, and compliant with regulatory standards.
Permission for Export Registration:
- Evaluate and submit applications to obtain Bioequivalence (BE) permissions for export registration.
Test/Analysis Permission:
- Evaluate and submit applications for permission to manufacture drugs for examination, testing, or analysis (Forms CT-10/12/13).
- Evaluate and submit applications for permission to import drugs for examination, testing, or analysis (Form-11/Form CT-17).
- Submit applications for permission to import drugs (Form 8) and for medical devices (MD-16) for examination, testing, or analysis.
Gazette Notifications & Compliance:
- Review draft Gazette notifications related to regulatory domains and share comments as necessary.
- Monitor regulatory changes and ensure that the company’s products remain in compliance with new and evolving regulations.
Market Complaints Response:
- Evaluate and submit responses to market complaints raised by regulatory authorities, ensuring all queries and issues are resolved promptly.

Education & Job Qualification:

Educational Qualification:
- M. Pharm (Master of Pharmacy) or equivalent degree.

Experience:

5-10 years of experience in Regulatory Affairs specifically for the Indian market.
Proven experience in regulatory submissions, including domestic registrations and import licenses for pharmaceutical products and medical devices.

Skills & Attributes:

Regulatory Knowledge: In-depth understanding of Indian regulatory requirements for drug and medical device registration, including the processes involved with DCGI and related authorities.
Attention to Detail: Ability to meticulously review documents, applications, and submissions to ensure compliance.
Communication Skills: Strong ability to communicate effectively with internal teams, regulatory bodies, and external stakeholders.
Problem-Solving: Skilled at resolving issues that may arise during the submission and approval process.
Collaborative: Ability to work cross-functionally with teams like R&D, quality assurance, and legal to ensure regulatory requirements are met.

Travel Estimate:

Travel may be required occasionally, depending on the need.

Compensation & Benefits:

Competitive salary and benefits package.
Opportunities for career advancement and professional growth in regulatory affairs.

Apply now to be part of a dynamic regulatory affairs team and help bring innovative products to market!

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