Analyst Regulatory Affair

Job Summary
We are seeking a detailoriented Analyst in Regulatory Affairs to oversee Emerging Markets procedures in Russia CIS markets to handle Marketing Authorization Application and ensure compliance with regulatory guidelines. Responsibilities include managing chemistry manufacturing and controls (CMC) documentation addressing deficiency letters contributing to regulatory strategy development and facilitating effective communication with stakeholders for successful product launches and regulatory compliance.


Roles & Responsibilities

You will be responsible for preparation review and submission of Dossier in various  Emerging Markets as per the applicable regulatory guidance in Emerging Markets.
You will be responsible authoring highquality chemistry manufacturing and controls (CMC) documentation for health authorities submissions applying agreed CMC global regulatory strategies assuring technical congruency and regulatory compliance throughout the project lifecycle.
You will be responsible to review of critical quality/regulatory documents like specifications stability protocols stability data development report justification reports etc.
You will be responsible for on time Response to deficiency letters.
You will be responsible for preparing Regulatory strategy notes regulatory due diligence and gap analysis for leverage products. Evaluating and sharing the Regulatory Affair requirements with product development teams at the product introduction stage performing regulatory due diligence and consolidated gap analysis for leveraging.

You will be responsible for providing inputs at every stage of development of the product.
You will be responsible for identifying all open issues and anticipated questions on regulatory submission at respective stage of product development Dossier filing and deficiency responses in consultation with team leads.
You will be responsible to review and closure of change control notifications (CCs) for under development under review and launch products in consultation with team lead.
You will be responsible to interact with Internal and External stakeholders/customers and provide timely regulatory guidance on various issues.

Qualifications :

Educational qualification: M Pharm in Pharma 

Minimum work experience: 36 years of experience in Regulatory affairs 

Skills & attributes: 
Technical Skills

• Knowledge on Regulatory requirements of all geographies.
• Understanding of product development manufacturing processes Intellectual Property and quality.
• Experience in GxP documentation computer system validation (CSV).
• Experience in incoming outgoing and product quality.

Behavioral Skills 

• Excellent communication and interpersonal skills.
• Efficient collaborator.
• Strong analytical and problemsolving abilities. 

Additional Information :

About the Department

Integrated Product Development Organisation                                         

We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused 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 :

Fulltime