Please find the job description for the role:
We are seeking an experienced Regulatory Affairs professional to join our Clients team in Mumbai, Powai location.
Location: Powai , Mumbai
Salary : Upto 7.00 Lacs
The successful candidate will be responsible for ensuring that our products comply with all regulatory requirements and standards. The role requires excellent communication, analytical and project management skills.
Responsibilities
- Develop and implement regulatory strategies for product approval and compliance
- Prepare and submit regulatory submissions to regulatory agencies
- Communicate with regulatory agencies regarding product approvals and compliance
- Monitor regulatory changes and provide guidance to cross-functional teams
- Collaborate with internal and external stakeholders to address regulatory issues
- Ensure compliance with company policies and procedures, as well as regulatory requirements
Skills and Qualifications
- Bachelor’s or Master’s degree in life sciences, pharmacy or related field
- 1-15 years of experience in regulatory affairs in the pharmaceutical or medical device industry
- Strong knowledge of FDA, EMA and other regulatory requirements and guidelines
- Experience with regulatory submissions and interactions with regulatory agencies
- Excellent communication and project management skills
- Ability to work independently and in a team environment
- Attention to detail and ability to prioritize workload
- Experience with electronic document management systems and regulatory databases
Kind Regards,
| Payal Gupta | Sr Recruitment Specialista: ELITE HR SOLUTIONS e: hr2@elitehrsolutions.in | w: www.elitehrsolutions.in |
Elite HR Services, a leading HR consultancy in India, specializes in people, team, and organizational assessment, development, and engagement. With an ever-expanding database, extensive client reach, and a strong network of experts, Elite hr efficiently connects skilled professionals with the right opportunities. Their large database and robust local presence make Elite the go-to choice for all human resource solutions.