BDR Pharmaceuticals, a leading name in the global pharmaceutical industry, is actively seeking a skilled Regulatory Affairs Executive to join our US market operations. This is an exciting opportunity for professionals with specialized experience in US FDA submissions and compliance to contribute to our mission of delivering innovative healthcare solutions. We are hiring immediately and building a pipeline of top-tier talent for future opportunities. If you’re a regulatory affairs professional looking to make an impact, read on to learn more about this role and how to apply.
Key Responsibilities
As a Regulatory Affairs Executive, you will play a pivotal role in ensuring compliance with US regulatory standards. Your responsibilities will include:
- Preparing and submitting regulatory documents to the US FDA, including IND, NDA, and ANDA applications.
- Ensuring compliance with FDA regulations, including 21 CFR Part 11, GMP, and other relevant guidelines.
- Collaborating with cross-functional teams to support product development and market approvals.
- Conducting regulatory assessments and gap analyses for new and existing products.
- Monitoring updates to US regulatory policies and advising internal stakeholders.
- Maintaining accurate documentation for audits and inspections.
Qualifications and Skills
To excel in this role, candidates must meet the following criteria:
- Minimum 4 years of experience in Regulatory Affairs, specifically with US FDA submissions.
- In-depth knowledge of US FDA regulations, including pre-market and post-market compliance.
- Strong understanding of pharmaceutical product lifecycles and regulatory pathways.
- Excellent communication and organizational skills.
- Ability to work on-site in the US market.
- Bachelor’s degree in pharmacy, life sciences, or a related field; advanced degrees preferred.
- Proven track record of successful FDA submissions is a plus.
Note: Candidates who do not meet the specified criteria are kindly requested not to apply at this time. We are building a talent pipeline and will consider your profile for future opportunities if you meet the requirements.
Benefits of Joining BDR Pharma
Joining BDR Pharma offers you:
- A chance to work with a globally recognized pharmaceutical leader.
- Opportunities for career growth in the US regulatory affairs landscape.
- A collaborative and innovative work environment.
- Competitive salary and comprehensive benefits package.
- The opportunity to contribute to life-changing healthcare solutions.
How to Apply
If you meet the qualifications and are ready to take the next step in your career, we’d love to hear from you! Please email your resume directly to dhairya.modi@bdrpharma.com
