Assistant Manager - Regulatory Affairs - Animal Health Firm

Job Opportunity with Multinational Animal Health Company.

Role: Regulatory Affairs

Level: Assistant Manager

Job Location : Mumbai (Santacruz, Kalina)

Domain : Animal Healthcare company

Responsibilities - 

Strategic/ Policy

- Plan, coordinate, and implement timely and effective processes for registration of new products and indications, and re-registration of existing products.

- Identifies changes in Regulatory policy & framework, macroeconomic and industry specific trends of relevance to organization in India. Projects industry changes over the planning horizon and develops strategies to best respond or leverage on changes.

- Ensures adherence to quality parameters & SOP in warehousing & supply

Operational

New Product Registration & renewals

- Develop regulatory strategies and implementation plans while coordinating with the business units for the identifications of products for future, preparation and submission of new products application.

- Will handle documentation relating to new product registration, including compilation of dossier, submission, correspondence, query response and follow-up till registration is accomplished

- Negotiates clinical trial contracts with Investigators regarding research grants. Ensures compliance with local laws and company SOPs

- Will liaise with colleagues from Manufacturing site & global to seek help for documentation & timely submissions.

- Will be a responsible for new product introduction and would give timelines for regulatory feasibility requirements.

- Will be responsible for assuring maintenance of approval status for all marketed products, including proactive suggestion of strategies when appropriate, and measures for regulatory safeguarding and defense of marketed products, if required

- Submission of variations &post approval changes, follow up till accomplishment.

- Maintenance of local license through various FDA.

- Support business for documentation pertaining to tender opportunities.

- Artwork development for new products.

Regulatory Documentation

- Will be responsible for maintaining all regulatory documentation in compliance with country regulations, this will include maintaining databases of regulatory status and other pertinent details. Maintenance of data of Customer Care queries, pharmacovigilance & PSUR

- Timely submission of variations & post approval changes to CDSCO.

- Well versed in usage of online system (SUGAM ) for submission.

External Regulatory Responsibilities

- Will manage regulatory actions related to associated markets such as Pakistan, Nepal, Sri Lanka, Bangladesh, Singapore, Myanmar & Cambodia.

- Will participate in activities directed towards influencing regulatory change and encouraging regional and international harmonization.

- Will liaise with various industrial & regulatory bodies to be updated on various changes on policies & guidelines.

- Will attend to queries from Customs, AQC, Ministry or state regulatory authorities.

- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

Quality

- Accompany Global auditors for quality audits of LSPs to ensure Good Distribution Practices are followed.

- Overview quality related activities at warehouses. Support on investigation of product quality complaints and deviations when related to Supply Chain and Logistics processes.

- Manage activities such as regulatory agency inspections, or product recalls

Financial

- Have registration costs incorporated into the departmental budget

- Support relevant departments on sales tax issues, Excise / Customs disputes, imports / exports.

- Support appropriate classification of products & HSN.

Technology

- Liaison with the IT function in order to develop systems for updating and maintaining regulatory records

- Identify technology solutions for enabling better information availability

- Use of various company systems for request, submissions&tracking of dossiers.

- Updating of quality systems to reflect correct status of LSP.

Qualifications (Training, Education & Prior Experience):

- B.V.Sc / M.Pharm

- 5-7 Years

Requirements

- Ability to deal with problems involving several concrete variables in standardized situations

- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions.

- Written Communication - Writes clearly and informatively; able to read and interpret written information.

- Problem Solving - Identifies and resolves problems in a timely manner; uses reason even when dealing with emotional topics.

- Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for l resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.

Special Skills & Knowledge

- In depth knowledge of Veterinary Science

- Multi-disciplinary technical knowledge

- Knowledge of manufacturing quality systems and processes

- Knowledge of regulatory laws and guidelines

- Knowledge of Import / Export regulations and registration/ regulatory procedures in neighboring countries as well as overseas markets

- General knowledge of regulatory affairs worldwide