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Regulatory Affairs Manager- India

Date: Jul 23, 2019

Location: Mumbai, MH, IN

Company: Glanbia

Glanbia is a leading global performance nutrition and ingredients group with leading market positions in cheese, whey proteins, sports nutrition and micronutrient premixes and our brands Optimum Nutrition and BSN are two of the world’s leading manufacturers of nutritional supplements in one of the fastest growing segments of the nutrition market. Our products are sold in over 130 countries worldwide and we employ 5,800 people across 30 countries, 60% of whom are in our international operations. Our shares are listed on the Irish and London stock exchanges and at GPN, our mission is to be the first choice of athletes and fitness enthusiasts everywhere to help achieve their goals through the highest-quality, most innovative performance nutrition products.

 

Job Title:    Regulatory Affairs Manager

Reports To:  Regional Director- South Asia

Supervises:  NA

Work Location:  Mumbai, India

Job Summary:

 

The Regulatory Affairs Manager is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.

 

Responsibilities:

  • Provide responses to regulatory agencies regarding product information or issues.
  • Involved in project implementation from regulatory perspective for Project Corridor & Project Gateway.
  • Train staff in regulatory policies or procedures.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Develop and maintain standard operating procedures or local working practices.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.
  • Participate in the development or implementation of clinical trial protocols.
  • Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
  • Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
  • Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives.

 

Knowledge, Skills and Abilities:  

  • Dealt with Government bodies like FSSAI, Animal Quarantine, Customs.
  • Strong leadership skills in managing/influencing teams.
  • Strong cross-functional project management skills.
  • Ability to work successfully in a highly-matrixed organization. Proven relationship builder.
  • Understanding of the dedicated sports lifestyle and a strong passion for building nutritional products that support this sector. 
  • Strong influencing skills across a culturally diverse group of people and markets
  • Persistence and resilience in the pursuit of objectives, willing to take on new challenges and works to resolve issues.
  • Ability to innovate and use initiative.
  • Strong ability to research, analyse and problem solve.
  • English is essential.
  • Good working knowledge of Microsoft Office and Adobe products.

 

Education/Experience:

 

  • Degree or equivalent or 12-15 years of related regulatory experience with administering local laws and regulations within the food and nutrition industries.
  • Needs to have a legal background with knowledge of food laws, food classification.
  • Experience drafting and negotiating Commercial Agreements relating to the manufacturing, sales, marketing of nutritional products
  • Experience in managing strategic manufacturing projects.
  • Experience working with regulatory consultants

     

NOTE: This job description is not intended, nor should it be construed to be an exhaustive list of all responsibilities, duties, skills, or working conditions associated with the particular job.  It is intended only to be a general description of the essential functions common to positions of this type.