Regulatory Affairs Executive – Shape the Future of Biologics and Injectables
Summary:
Join our dynamic Regulatory Affairs team and play a pivotal role in bringing innovative injectables, medical devices, biosimilars, vaccines, and biological products to market. We are seeking a highly motivated and experienced Regulatory Affairs Executive with a strong understanding of global regulatory requirements and a passion for ensuring compliance. If you possess a B.Pharm or M.Pharm degree and 2-5 years of hands-on experience in regulatory submissions for the pharmaceutical sector, we encourage you to apply. This is an exceptional opportunity to contribute to a growing organization at the forefront of pharmaceutical innovation.
About Us:
We are a rapidly expanding pharmaceutical company dedicated to developing and delivering cutting-edge therapies that improve patient lives. Our commitment to innovation, quality, and regulatory compliance drives our success in the global healthcare landscape. As a member of our team, you will be part of a collaborative and supportive environment where your expertise and contributions will be valued and recognized.
Job Description:
As a Regulatory Affairs Executive, you will be responsible for preparing, reviewing, and submitting regulatory documentation for a diverse portfolio of products, including injectables, biologicals, biosimilars, vaccines, and medical devices. You will work closely with cross-functional teams to ensure timely submissions, maintain regulatory compliance, and contribute to the development of regulatory strategies.
Key Responsibilities:
- Documentation and Submissions: Prepare, review, and submit comprehensive regulatory documentation packages for domestic and international markets. This includes but is not limited to INDs, NDAs, ANDAs, MAAs, and other relevant regulatory filings.
- Compliance Management: Ensure ongoing compliance with applicable regulations and guidelines (ICH, CDSCO, USFDA, EMA, etc.). Monitor changes in regulatory requirements and proactively implement necessary adjustments.
- Cross-Functional Collaboration: Collaborate effectively with research and development, manufacturing, quality control, and other departments to gather necessary data and documentation for regulatory submissions.
- Product Lifecycle Management: Support all stages of the product lifecycle, from new product registrations and variations to renewals and post-approval updates.
- Regulatory Intelligence: Maintain a thorough understanding of evolving regulatory guidelines and industry best practices. Provide guidance on regulatory requirements to internal teams.
- Strategy and Dossier Readiness: Assist in the development of regulatory strategies and ensure the readiness of regulatory dossiers for submission.
- Risk Assessment: Identify potential regulatory risks and develop mitigation strategies.
- Communication: Effectively communicate regulatory information to internal and external stakeholders.
- Problem Solving: Resolve regulatory issues and challenges in a timely and efficient manner.
Required Qualifications:
- Education: B.Pharm or M.Pharm degree is mandatory.
- Experience: 2–5 years of core experience in Regulatory Affairs within the pharmaceutical industry.
- Technical Expertise:
- Strong hands-on experience with injectables, biological products & biosimilars, vaccines, and medical devices.
- In-depth knowledge of CTD, ACTD, and eCTD formats.
- Understanding of regulatory pathways for pharmaceutical products in various markets.
- Experience in preparing and submitting regulatory applications to regulatory agencies.
- Skills:
- Excellent documentation and compliance skills.
- Strong analytical and problem-solving abilities.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite and other relevant software applications.
- Attention to detail and accuracy.
- Ability to prioritize tasks and manage multiple projects simultaneously.
Benefits:
- Opportunity: Work on cutting-edge biological and injectable products with significant impact on patient care.
- Growth: Benefit from a growth-oriented environment with opportunities for professional development and learning.
- Compensation: Receive a competitive industry-aligned compensation package, including benefits.
- Collaboration: Work alongside cross-functional scientific and regulatory experts in a supportive and collaborative environment.
- Impact: Contribute directly to bringing innovative therapies to patients in need.
How to Apply:
If you are a highly motivated and qualified Regulatory Affairs professional seeking a challenging and rewarding opportunity, we encourage you to apply. Please submit your resume and cover letter through our website. We look forward to hearing from you!