Regulatory Affairs Specialist – EU

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team.  We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. 

Job Summary:

Seeking a skilled Regulatory Affairs Specialist with expertise in European pre- and post-approval submissions. This role involves managing regulatory processes, ensuring compliance, and providing strategic guidance for EU market filings.

Key Responsibilities:

• Oversee pre- and post-approval submissions for the European market, ensuring compliance with regulatory standards.
• Evaluate and document post-approval changes, ensuring precise classification and adherence to EU requirements.
• Prepare, review, and submit variations and renewals for EU products, coordinating effectively with cross-functional teams.
• Interact with global regulatory colleagues to facilitate timely approvals and updates.
• Address regulatory deficiencies promptly, ensuring compliance with agency requirements.
• Communicate effectively with Regulatory Authorities and IL Customers, ensuring clear and professional correspondence.
• Provide regulatory strategies and guidance to IL partners and cross-functional teams.
• Support manufacturing sites during regulatory audits, ensuring compliance with GMP/QMS standards.
• Manage Marketing Authorization (MA) transfer activities within the EU market.
• Utilize Regulatory Information Management Systems (RIMS), Veeva, and publishing tools for efficient submissions and documentation.

Qualifications:

• Master of Pharmacy (M.Pharm).

Skills & Competencies:

• Strong understanding of EU regulatory requirements, publishing processes, and eCTD submissions. -National, MRP/DCP, CP, CESP.
• Excellent communication and interpersonal skills, particularly in regulatory interactions.
• Expertise in GMP, QMS, and plant operations to support compliance initiatives.
• Familiarity with RIMS, Veeva, and publishing tools for streamlined document submission.

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
 
Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

For more details, please visit our career website at https://careers.drreddys.com/#!/