Specialist - Regulatory Affairs - Pharmaceuticals

Domnic Lewis is a successful and innovative recruitment firm that works with Fortune 500 companies, has a strong commitment to diversity in hiring, and uses talent mapping as a key part of its recruitment process. The company operates in North America, India, and Australia, and has recently entered the gig hiring market by building communities. It has also been recognized for its efforts in diversity hiring through awards.

Website: https://www.cerentral.com/

Currently we are looking for a "Regulatory Affairs Specialist" for a leading pharmaceutical MNC.

Job Location : Bangalore

Job Description :

Responsibilities :

- Plan, prepare, and submit high-quality files to health authorities for fast approvals

- Work as an integrated part of global cross-functional teams with stakeholders from various departments

- Prepare and deliver meeting packages to Health Authorities

- Conduct Health Authority interactions and seek regulatory approvals globally

- Demonstrate subject matter expertise in regulatory science and global Life Cycle Management activities

Key Duties :

- Compile, review, and submit pre-meeting packages for authority meetings

- Handle post-approvals, query responses, and change requests from Quality Assurance

- Submit regulatory files, respond to health authorities, and maintain marketing authorizations worldwide

- Manage Pharmacovigilance documentation, including Drug Safety Update Reports, Periodic Safety Update Reports, Investigation Brochures, Clinical Trial Reporting, and clinical trial applications

- Handle Life Cycle Management (LCM) of the product, including maintaining clinical file protocols and interim study reports

Qualifications :

- 10+ years of experience in Regulatory Affairs, specifically in CMC/NDA/Clinicals

- Graduate or postgraduate degree required

- Experience in handling health authorities, government bodies, and local market authorities

- Experience in life cycle management of products

- Global exposure in handling different markets

- Excellent communication and presentation skills

- Bold and strong personality with proven negotiation skills

- Self-managed with a strong personal drive

- Team player with the ability to engage with colleagues and peers

- High cultural sensitivity and comfortable working across different countries and time zones.