Specialist Regulatory Affairs NBE

Specialist Regulatory Affairs Novel Biological Entity is responsible for driving global regulatory strategy submission planning and lifecycle management for novel biological products across key emerging markets. The role involves close collaboration with cross-functional teams to ensure timely approvals compliance with regulatory requirements and successful market entry.

Key Responsibilities:

• Lead end-to-end regulatory activities for innovative biological product portfolios across global markets (Emerging Markets).
• Develop and execute regulatory strategies aligned with business objectives and market requirements.
• Oversee preparation review and submission of dossiers (CTD/eCTD) including IND/IMPD/CTA MAA variations amendments and renewals.
• Act as the primary point of contact with country affiliates and global health authorities for regulatory interactions queries and inspections.
• Provide strategic guidance on regulatory pathways for biological products including clinical requirements of country of origin or single region clinical study data.
• Ensure compliance with evolving regulatory frameworks guidelines and quality standards.
• Collaborate with partners and cross-functional teams (R&D Quality Clinical Medical Manufacturing commercial marketing and supply Chain) to drive regulatory milestones.
• Identify risks in submission timelines and proactively implement mitigation plans.

Key Requirements:

• Advanced degree in Pharmacy Biotechnology or related field.
• Strong experience in Regulatory Affairs with exposure to biosimilars or biologicals.
• Proven experience in handling global submissions (ANVISA SAHPRA DIGIMED TGA MEDSAFE COFEPRESSUSFDA EMA or other major agencies).
• Strong understanding of biosimilar regulatory frameworks and lifecycle management.
• Excellent communication strategic thinking and stakeholder management skills.

Key Competencies:

• Regulatory Strategy & Compliance
• Global Stakeholder Management
• Analytical & Problem-Solving Skills
• Strong Execution & Ownership

Qualifications :

Educational qualification: Post graduate in Pharmacy/Science

Minimum work experience: 8 years in Pharmaceutical Industry with 5 years of experience in global regulatory affairs.

Skills & attributes: 
Technical Skills
Experience in formulation development analytical development and quality.
Understanding of Good Manufacturing practice/Quality Systems.
Understanding of product development manufacturing processes Intellectual Property and quality.
Technical knowledge and understanding of the regulatory requirements of different dosage forms.
Thorough understanding of regulatory guidelines for different countries ICH guidelines pharmacopeias product filing and approval requirements.

Behavioural Skills 
Excellent communication and interpersonal skills.
Efficient Leader and a good collaborator.
Good influencing skills.
Strong analytical and problem-solving abilities.

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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.
For more details please visit our career website at

Remote Work :

No

Employment Type :

Full-time