Job Description:-
Department:RA-API
Qualification:M.Pharma/M.Sc
Experience:3-6 Years
Working Days:6-Days Work
Job Location:Unit 1,IDA Uppal, Hyderabad
Here is a comprehensive job description for various roles in a Regulatory Affairs department:
Regulatory Affairs Department Job Descriptions
1. Regulatory Affairs Specialist
- Job Summary: Ensure compliance with regulatory requirements for pharmaceuticals, biologics, or medical devices.
- Key Responsibilities:
- Review and analyze regulatory guidelines.
- Prepare and submit regulatory documents (e.g., IND, NDA, BLA).
- Coordinate with cross-functional teams (e.g., R&D, Quality).
- Monitor regulatory changes and updates.
- Skills and Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- 2+ years of experience in regulatory affairs.
- Knowledge of FDA regulations, ICH guidelines, and GMP.
2. Senior Regulatory Affairs Specialist
- Job Summary: Lead regulatory strategy and compliance efforts.
- Key Responsibilities:
- Develop and implement regulatory strategies.
- Manage regulatory submissions and approvals.
- Collaborate with regulatory agencies.
- Mentor junior regulatory staff.
- Skills and Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- 5+ years of experience in regulatory affairs.
- Advanced knowledge of FDA regulations, ICH guidelines, and GMP.
3. Regulatory Documentation Specialist
- Job Summary: Prepare and maintain regulatory documents.
- Key Responsibilities:
- Create and edit regulatory documents (e.g., SOPs, protocols).
- Ensure document compliance with regulatory requirements.
- Manage document control and versioning.
- Collaborate with cross-functional teams.
- Skills and Qualifications:
- Bachelor’s degree in English, Communications, or related field.
- 2+ years of experience in regulatory documentation.
- Knowledge of document control systems.
4. Regulatory Compliance Officer
- Job Summary: Ensure compliance with regulatory requirements.
- Key Responsibilities:
- Monitor regulatory changes and updates.
- Conduct audits and inspections.
- Identify and mitigate compliance risks.
- Collaborate with cross-functional teams.
- Skills and Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- 2+ years of experience in regulatory compliance.
- Knowledge of FDA regulations, ICH guidelines, and GMP.
5. Regulatory Affairs Manager
- Job Summary: Lead regulatory affairs department.
- Key Responsibilities:
- Develop and implement regulatory strategies.
- Manage regulatory staff.
- Collaborate with senior management.
- Ensure regulatory compliance.
- Skills and Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- 8+ years of experience in regulatory affairs.
- Advanced knowledge of FDA regulations, ICH guidelines, and GMP.
Keep in mind that specific responsibilities, skills, and salary ranges may vary depending on the company size, location, and specific job requirements.
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If You are Interested for this Job then Contact Number Given below
Contact:9390435461