Regulatory Affairs

JOB ROLE

International Regulatory Role

JOB CODE

TBD

DEPARTMENT

Regulatory Affairs

JOB LOCATION

Gurgaon

BAND LEVEL

T

DESIGNATION

Deputy Manager

JOB PURPOSE

  RELATIONSHIP & REPORTING STRUCTURE

DIRECT SUPERVISOR / MANAGER

R&D Head

SKIP LEVEL MANAGER

JMD

NO. OF DIRECT REPORTS

NA

DOTTED LINE MANAGER

NA

  AREAS OF RESPONSIBILITIES

ROLES & RESPONSIBLITIES

·         Collect and coordinate information to prepare regulatory documentation for submission to international regulatory agencies.

·         Able to handle International Product registration.

·         Preparation of Product related Dossiers for International registration.

·         Registration of agrochemicals in the given country/territory as per regulatory framework.

·         Regulatory project management, preparing, implementing, communicating, and coordinating regulatory projects.

·         Maintain regulatory knowledge and databases, prepare documents, dossiers, liaison with technical experts and Regulatory managers for reports, studies and technical data.

·         Keeping pace with changing guidelines and regulatory requirements.

·         Co-ordination with R&D, and production plants for arranging the samples for data development and sending to customers/ regulatory authorities.

·         Preparation of required documents for sample dispatch and tracking till samples reach their destination.

·         Ensure that product creation and marketing, labelling and branding elements are in line with all regulatory specification relating to Agro Chemicals.

·         Liasoning with government bodies and meeting registration timelines.

·         Coordinating with external agencies ICAR, CIB, other consultants etc.

·         Perform literature searches and extract information to support regulatory submissions.

·         Compiling and submitting registration dossiers as per the defined timeline.

·         Replying to the queries received on the registration dossier in consultation with seniors.

·         Documentation and filing of reports, registration certificates etc.

·         To prepare regulatory dossier on chemistry and residue, as per company and timelines

COMPETENCIES

FUNCTIONAL COMPETENCIES

·          Well aware of the protocols of different countries & international regulatory authorities.

·         Should be able to submit the reports on timely basis & with accuracy

BEHAVIORAL & FINACTIONAL COMPETENCIES

·         Mature, able to manage multiple tasks effectively and efficiently, work under pressure and meet tight deadlines

·         Must have a positive attitude and strong interpersonal skills.

·         Strong desire for continued growth and learning

·         Good Analytical skills

JOB REQUIREMENTS

TOTAL EXPERIENCE

7-8 years of experience in international registration

EDUCATION REQUIREMENTS

MSc in Organic Chemistry

LOCATION

Gurgaon

INDUSTRY

Agrochemical Industry