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Title
Text copied to clipboard!Regulatory Affairs Specialist - Pharma
Description
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We are looking for a highly skilled and detail-oriented Regulatory Affairs Specialist to join our pharmaceutical team. The ideal candidate will be responsible for ensuring that our products comply with all regulations and guidelines set by regulatory agencies. This role involves preparing and submitting regulatory documents, maintaining regulatory files, and staying updated on changes in regulations. The Regulatory Affairs Specialist will work closely with various departments, including research and development, quality assurance, and marketing, to ensure that all regulatory requirements are met. This position requires a deep understanding of pharmaceutical regulations, excellent communication skills, and the ability to manage multiple projects simultaneously. The successful candidate will have a strong background in regulatory affairs, a keen eye for detail, and the ability to work effectively in a fast-paced environment. If you are passionate about ensuring the safety and efficacy of pharmaceutical products and have a strong regulatory background, we would love to hear from you.
Responsibilities
Text copied to clipboard!- Prepare and submit regulatory documents to regulatory agencies.
- Maintain and update regulatory files and databases.
- Ensure compliance with all applicable regulations and guidelines.
- Monitor changes in regulatory requirements and communicate updates to relevant departments.
- Collaborate with research and development, quality assurance, and marketing teams.
- Review and approve product labeling and advertising materials.
- Conduct regulatory risk assessments and provide guidance on regulatory strategies.
- Participate in regulatory inspections and audits.
- Develop and implement regulatory policies and procedures.
- Provide training on regulatory requirements to internal teams.
- Liaise with regulatory agencies and respond to inquiries.
- Prepare and submit regulatory reports and filings.
- Ensure timely approval of new products and changes to existing products.
- Maintain knowledge of current and emerging regulations and industry standards.
- Support product development teams with regulatory guidance.
- Review and approve clinical trial protocols and reports.
- Manage regulatory submissions for international markets.
- Ensure accurate and complete documentation of regulatory activities.
- Participate in cross-functional project teams.
- Provide regulatory support during product recalls and other compliance issues.
Requirements
Text copied to clipboard!- Bachelor's degree in a scientific or related field.
- Minimum of 3-5 years of experience in regulatory affairs in the pharmaceutical industry.
- Strong knowledge of pharmaceutical regulations and guidelines.
- Excellent written and verbal communication skills.
- Ability to manage multiple projects and deadlines.
- Detail-oriented with strong organizational skills.
- Proficiency in regulatory submission software and databases.
- Experience with regulatory submissions for both domestic and international markets.
- Ability to work effectively in a team environment.
- Strong problem-solving and analytical skills.
- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
- Ability to interpret and apply regulatory requirements.
- Experience with regulatory inspections and audits.
- Strong interpersonal skills and the ability to build relationships with regulatory agencies.
- Ability to provide regulatory guidance to cross-functional teams.
- Experience with electronic document management systems.
- Ability to stay updated on changes in regulations and industry standards.
- Strong project management skills.
- Ability to work independently and take initiative.
- Proficiency in Microsoft Office Suite.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with regulatory submissions in the pharmaceutical industry?
- How do you stay updated on changes in pharmaceutical regulations?
- Can you provide an example of a challenging regulatory issue you faced and how you resolved it?
- How do you ensure compliance with regulatory requirements in a fast-paced environment?
- What experience do you have with international regulatory submissions?
- How do you handle multiple projects with tight deadlines?
- Can you describe your experience with regulatory inspections and audits?
- How do you collaborate with cross-functional teams to ensure regulatory compliance?
- What strategies do you use to manage regulatory risks?
- Can you provide an example of a successful regulatory submission you managed?
- How do you ensure accurate and complete documentation of regulatory activities?
- What experience do you have with electronic document management systems?
- How do you provide regulatory guidance to product development teams?
- Can you describe your experience with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)?
- How do you handle regulatory inquiries from agencies?
- What training have you provided on regulatory requirements to internal teams?
- How do you manage regulatory submissions for new products and changes to existing products?
- Can you describe your experience with regulatory risk assessments?
- How do you ensure timely approval of regulatory submissions?
- What tools and software do you use for regulatory submissions and tracking?