Regulatory Affairs Specialist
On-siteNanakramguda, State of Telangāna, Republic of India
Job Summary
Prepare, review, file, and support premarket documents for global registrations while collaborating with business unit and international regulatory affairs personnel to secure marketing authorizations. Review pre-clinical and clinical protocols for submissions, develop regulatory strategies for new or modified products, and monitor changes in the regulatory environment. Document communications with health authorities, compile submission materials for license renewals, and participate in agency inspections and audits. Author and review regulatory procedures, assess change control documents, and ensure compliance for product raw materials and prototypes. This role supports design and development control activities within a team environment, requiring a Bachelor's degree and 4-7 years of experience in medical device or pharmaceutical regulatory affairs.
Required Qualifications
- Bachelor's degree in medical, Mechanical, Electric Life Science or other healthcare related majors
- 4-7 year's experience for RA role in medical device and or pharmaceutical industry
- Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements
- Excellent written, organizational, and communication skills
- Flexible and team-oriented attitude
- Strong attention to details
- Ability to handle multiple tasks
- Good at planning
- Ability to work under pressure
- Good at English including reading, writing, and speaking
- Good Learning attitude
- Ability to manage projects to completion within and outside of the direct department and company
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
- Proactively seeks to develop and become well-versed within the regulatory landscape
- Ability to work well under pressure in a dynamic environment
- Highly organized, detail-oriented, and efficient
- Team player who seeks to help and learn from colleagues seeing the department success as their own
- Experience with solving problems and concerns
- Experience with project management and adherence to time schedules
- This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees
Desired Qualifications
- A mix is preferred in case of pharma
- Nice to Have US and global regulatory affairs knowledge and experience
- Experience working with cross-functional teams
- Effective verbal and written communication skills both internally and externally
- RAPS Regulatory Affairs Certification (RAC)
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