Regulatory Affairs Specialist - API

Job Summary
We are seeking a dynamic and experienced Team Lead in Global Regulatory Affairs API team to provide guidance and support to the team in their operations. Provide guidance on product & regionspecific regulatory requirements to the development team for new products & life cycle management activities planned at manufacturing sites. Provide prompt regulatory support to the customers and review of the regulatory submissions to ensure new submissions as per the scorecard commitments. Ensure timely response to deficiencies received from regulatory agencies & customers and global life cycle management submissions as per the schedule.  

Roles & Responsibilities
You will be responsible to define the regulatory requirements for selection of Drug Master File starting materials and their suppliers. Guide the teams for setting specifications for the starting materials intermediates & Active Pharmaceutical Ingredient and provide inputs for defining the control strategy for PGIs nitrosamines & any other regulatory expertise required based on scope of the products for line extensions to other markets such as China Brazil Europe Japan & others. Participate in discussions related to new product development phase gate meetings and integrated product meetings with Formulation teams. 

You will be responsible for ensuring the smooth of regulatory filings globally according to the established plan by collaborating with Product Delivery Managers/Project Managers. Monitor and assess the progress of Drug Master File (DMF) preparation reviewing the submissions to ensure adequate quality. Develop submission strategies for alternate synthetic processes/sites liaise with regional points of contact for timely submissions and ensure comprehensive and timely responses to regulatory queries from various geographies.

You will be responsible for ensuring the Drug Master File (DMF) aligns with Brazil China Japan Europe Canada Russia and other Countries regulatory standards overseeing the closure of identified gaps within stipulated timeframes guiding team members during Health Product Technical (HPT) interactions for integrating global regulatory requirements in new product development. Additionally facilitate collaboration with the frontend team for a robust submission plan engaging in periodic customer teleconferences to resolve queries and ensure DMF readiness for customers globally with minimal queries.

You will be responsible to ensure the Drug Master File (DMF) deficiency letters received from various regulatory agencies globally are responded in time with adequacy and accuracy. Review the action points with the team members and guide them in case of any unresolved or complex deficiency points.

You will be responsible for scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements including continuous improvement programs alternate vendor development programs operational excellence and trouble shooting. Defining appropriate regulatory strategies for life cycle management activities by applying regulatory science in collaboration with the technical teams. Additionally facilitate collaboration with front end teams and customers to ensure the submission and approval of supplements / variations on time. 

You will be responsible for maintaining uptodate knowledge of evolving regulatory requirements across managed geographies fostering knowledge sharing within the team through regulatory guideline dissemination and training sessions. Facilitate the upskilling of team members to align with the evolving International Council for Harmonization (ICH) guidelines to comprehend insights from regulatory deficiencies customer queries and updates from conferences/trainings. Ultimately aim to serve as an internal API regulatory expert ensuring regulatory compliance within the team and crossfunctional teams.

You will be responsible to conduct periodic reviews of the team members to take stock of the progress & delays and intervene upon necessity. Enable the team for decision making for resolving issues and guide the team in goal setting conduct performance appraisals. 

Qualifications :

Educational qualification: Post Graduate in Organic Chemistry/Pharma

Minimum work experience: 1012 years in API Regulatory Affairs with a fair understanding of GMP & Quality systems.

Skills & attributes: 
Technical Skills

• Knowledge of global regulatory requirements new product development manufacturing quality & Intellectual Property Management.
• Understanding of geographic specific regulatory requirements versus customer expectations & market play.
• Regulatory requirements of all geographies especially Generic Drug User Fee Amendments (GDUFA) Brazil China Japan Europe Russia Canada etc..
• Understanding of Good Manufacturing practice/Quality Systems.
• Understanding of Pharmaceutical product value chain Intellectual Property and quality.
• Thorough understanding of regulatory guidelines for United States/ Europe ICH guidelines pharmacopeias product filing and approval requirements.
• InterCultural Understanding & Awareness is a must

Behavioral Skills 

• Excellent communication and interpersonal skills.
• Efficient Leader and a good collaborator.
• Good influencing skills.
• Strong analytical and problemsolving abilities.
• Ability to take calculated risks.

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