Graviti Pharmaceuticals, a leading research-driven pharmaceutical company based in Hyderabad, is expanding its regulatory team with an exciting opportunity for a seasoned professional. If you have extensive experience in regulatory affairs for the European market and a passion for driving compliance excellence, this Senior Manager Regulatory Affairs role could be your next career move.
With a strong focus on complex generics, solid oral and sterile dosage forms, Graviti Pharmaceuticals is committed to delivering high-quality, innovative solutions globally. This position offers the chance to lead strategic submissions, mentor teams, and contribute to the company’s growth in international markets.
Key Roles and Responsibilities
As Senior Manager – Regulatory Affairs (Europe Market), you will play a pivotal role in ensuring seamless regulatory compliance. Your primary duties will include:
- Evaluating and developing regulatory submission strategies for the European market
- Preparing and managing dossier submissions to European regulatory authorities
- Hands-on expertise with Solid Oral and/or Sterile dosage forms
- Overseeing post-approval activities, including variations and lifecycle management
- Coaching and mentoring team members to build proficiency in regulatory processes
- Collaborating with cross-functional teams to align on regulatory requirements and timelines
This leadership position demands strategic thinking and the ability to navigate complex regulatory landscapes effectively.
Required Qualifications and Experience
We are seeking a highly skilled candidate with:
- Over 12 years of experience in pharmaceutical regulatory affairs
- Strong exposure to the European (EU) market regulations and submission processes
- Proven leadership skills and experience in team mentoring
- In-depth knowledge of dossier preparation, submissions, and post-approval management
- Expertise in Solid Oral and/or Sterile dosage forms
- Excellent communication and problem-solving abilities
- A relevant degree in Pharmacy, Life Sciences, or related fields (advanced qualifications preferred)
The ideal candidate is passionate about regulatory excellence and thrives in a dynamic, growth-oriented environment.
Salary, Benefits, and How to Apply
Graviti Pharmaceuticals offers a competitive compensation package for this senior role, with an expected salary range of INR 25-35 Lakhs per annum, depending on experience and qualifications. Benefits include health insurance, performance incentives, professional development opportunities, and a supportive work culture.
To apply, interested candidates should send their updated resume to Rajesh.a@gravitipharma.com or contact 7075201677 (WhatsApp or calls preferred during office hours).
Join Graviti Pharmaceuticals and contribute to shaping the future of global healthcare through regulatory innovation and leadership.
