Head Regulatory Affairs- Nutrition

4 weeks ago

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

Job Summary
We are looking for a seasoned Head Regulatory Affairs to lead the regulatory strategy, ensuring compliance with health product regulations and fostering organizational growth through effective regulatory management. Your role will involve providing regulatory expertise throughout product development, maintaining compliance with local and corporate regulations, and managing regulatory approvals and support for in-licensing opportunities.

Roles & Responsibilities
Mandatory Knowledge/Skills : 

Business Understanding

  • Experience of the complete nutrition and nutraceutical market along-with additional knowledge of
  • Understanding of Food Supplements and their relationship to Human Physiology/ Health/ Diseases
  • Experience in Identifying & Evaluating the new product regulatory strategy during the ideation stage to minimize risks during the product development cycle.
  • Understanding of regulatory claim strategies and applying the principles of scientific / regulatory interpretation and evaluation to innovation in nutrition and nutraceuticals
  • Ability to understand the current and future business trends for the nutrition market
  • Very clear risk assessment understanding based on market trends and regulatory policy changes

Functional requirements

  • Detailed Knowledge of regulatory processes in key regions such as India , SEA,LATEM,EU, China, USA  for food and food supplements including herbals.
  • Knowledge in working/ representing scientific regulatory issues at  regulatory forums in India and global level
  • Knowledge of the broader market understanding and competitor landscape in the space especially infant, pediatric, adult and hospital nutrition segment, food supplements and OTC products. 
  • Knowledge of dossier development, and leading project management of regulatory dossiers across multiple markets
  • Leading the cross functional alignment for successful delivery of dossiers across markets including regulatory publishing management
  • Leading regulatory discussions and enabling local country teams with efficient process management while keeping business targets on time.
  • Ability to manage and lead RA-QA interface for India & other markets
  • Ability to integrate the local nuances at design , deploy and maintenance stage of various dossiers across markets  
  • Knowledge of the various nuances of the Food & Nutrition Consumer Industry & Market Trends and its application to regulatory strategy and compliance include categorization
  • very clear understanding and interpretation of regulatory laws and guidance including update both and India and US/ EU level

Key Behavior

  • Ability to lead, problem solve, work in teams and present complex data clearly
  • Able to manage cross-functional internal and external stakeholders and manage cross cultural nuances
  • Ability to interact externally and internally to drive the business strategy in India and other markets including reputation building for DRL
  • Possess excellent interpersonal skills,communication, coordination, and time-management skills
  • Therapeutic nutrition knowledge base desired however orientation to science based solutions a must
  • Adaptable and have the ability to work under a wide variety of conditions 

Qualifications

Educational qualification: Bachelor’s or Master’s Degree

Minimum work experience: 10+ years

Skills & attributes:
• Understanding the regulatory legislation and environment in South Africa.
• Excellent communication, interpersonal and negotiation skills.
• Excellent leadership and people management skills.
• Aspirational growth mind-set and results driven.
• Speed and rigour in execution.
• People leadership, innovation skills, and excellence focus.
• Egalitarian, trust, flexibility, adaptive, assertive, taking initiative.
• Planning and organizational skills.
• Ability to multi-task and work under time constraints.



Additional Information

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.

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