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Regulatory Affairs Specialist

1 month ago

Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time
Job Description

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 & region-specific 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 execution 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 front-end 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 up-to-date 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 cross-functional 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: 10-12 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, pharmacopeia's, product filing and approval requirements.
  • Inter-Cultural Understanding & Awareness is a must

Behavioral Skills 

  • Excellent communication and interpersonal skills.
  • Efficient Leader and a good collaborator.
  • Good influencing skills.
  • Strong analytical and problem-solving abilities.
  • Ability to take calculated risks.
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 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

Benefits Offered
At Dr. Reddy's we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddy's 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. 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.
For more details, please visit our career website at https://careers.drreddys.com/#/