MakroCare Hiring: Regulatory Affairs Specialist
About Company:
MakroCare, based in Hyderabad, Telangana, is a leading provider of regulatory and clinical development solutions. We specialize in clinical research, regulatory submissions, and scientific communication, delivering high-quality, innovative solutions to the pharmaceutical, biotechnology, and medical device industries.
Position Name:
Regulatory Affairs Specialist
Organization:
MakroCare
Qualification:
- B.Pharm
- M.Pharm
- M.Sc
- B.Sc in Life Sciences
Experience:
4-8 years
Salary:
CTC: ₹8.10 LPA
Location:
Hyderabad
Job Description:
As a Regulatory Affairs Specialist at MakroCare, you will manage and oversee regulatory submissions and communications with drug regulatory authorities, ensuring compliance with CMC, eCTD/CTD requirements, and keeping up with regulatory changes in the US, UK, EU, and ROW markets.
Key Responsibilities:
- Prepare and review regulatory submissions in compliance with CMC, eCTD/CTD requirements.
- Ensure timely and accurate submissions to regulatory authorities in the US, UK, EU, and ROW markets.
- Monitor and interpret regulatory requirements and guidelines.
- Ensure compliance with all relevant regulatory standards and policies.
- Handle the publishing and submission of regulatory documents.
- Manage and maintain submission tracking systems.
- Develop and implement regulatory strategies for successful product registration and maintenance.
- Liaise with regulatory authorities and provide strategic guidance on regulatory matters.
- Work closely with cross-functional teams including R&D, Quality Assurance, and Clinical Development.
- Provide regulatory support and guidance throughout the product lifecycle.
- Maintain accurate and up-to-date regulatory documentation and records.
- Prepare reports and documentation for internal and external audits.
Eligibility Criteria:
| Education | Experience | Skills and Abilities |
|---|---|---|
| Bachelor’s or Master’s degree in Life Sciences | 4-8 years in Regulatory Affairs | Strong analytical and problem-solving skills |
| B.Pharmacy or M.Pharmacy | Experience with CMC, eCTD/CTD requirements | Excellent written and oral communication skills |
| Regulatory publishing and submission processes | Detail-oriented with a focus on compliance and quality | |
| Knowledge of US, UK, EU, and ROW markets | Ability to manage multiple projects and deadlines | |
| Proficiency in regulatory submission software and tools |
Meta Description:
Join MakroCare in Hyderabad as a Regulatory Affairs Specialist. Ensure compliance and manage regulatory submissions. Apply now!