Regulatory Affairs Specialist - Ottawa, United States - SIGAN AMERICA, LLC

Description

Position Summary:

The Senior Regulatory Affairs Specialist will be responsible for performing a wide variety of tasks to

ensure global compliance with all cosmetic and OTC regulatory requirements. This position will be

responsible for supporting global regulatory programs and strategies by working collaboratively with

his/her supervisor and key business partners. He/she will support new & existing products, process

improvements, and global market compliance as appropriate.

This position will be responsible for supporting and implementation of the required processes, protocols

and programs necessary to support compliant and robust regulatory practices throughout the company.

Functional Responsibilities:

 Completes assignments related to FDA and global regulatory compliance matters including

supporting general quality system related initiatives.

 Responsible for supporting the management of in-market representative bodies.

 Ensures documentation related to regulatory matters, process, and product / label change control

are accurate and compliant.

 Works collaboratively with cross-functional project teams to complete regulatory related

assignments for both new and existing products. Clearly articulates requirements to colleagues.

 Responsible for supporting and taking the lead as appropriate regarding cosmetic/OTC

international product registration's and the establishment of compliant Dossier's.

 Responsible for assisting/supporting supervisor regarding REACH Law initiatives.

 Works with support of supervisor to review, ideate and approve marketing messages, promotional

 documents, product claims and labeling ensuring risk-based regulatory compliance for new and

existing products.

 Provides regulatory guidance and training as appropriate ensuring compliance with all regulatory

 requirements in existing and new markets.

 Manages entry of data into WERC'S and generates SDS's as appropriate.

 Reviews global regulations/guidance documents and works with his/her supervisor and

colleagues as appropriate to develop strategies that ensure ingredient, packaging component,

printing inks/pigments and finished product compliance.

 Monitors, interprets, makes recommendations to update product compositions, company

procedures and documents with respect to forthcoming and/or changing state, US and global

regulatory requirements.

 Works with supervisor to develop and communicate regulatory compliance requirements in

support of NPD (New Product Development) Process.

 Maintains regulatory files including claims support packages for new and existing products to

ensure compliance and support/defend legal inquiries/challenges and regulatory audits.

 Responsible for supporting the timely filing of all US annual licenses for OTC Drugs and

cosmetic personal care products (MoCRA)

 Works with supervisor and Department Head to provide regulatory guidance with respect to short

andlong term business planning. Keeps R&D team updated of changing regulations and develops

formulation guidelines.

 Create Master Batch Records for all new and existing products for production.

 Create and maintain product information files (PIFs) for all new and existing raw materials.

 Log and maintain all raw materials ordered by R&D and Purchasing

 Recognizes urgency and reacts timely with necessary information or actions

 Prioritizes actions and activities to meet expectations, including changing expectations.

 Adjusts actions in response to situations and available information.

 Understands the importance of new information for both current and future problem-solving and

decision-making, with regards to regulation and compliance.

Experience:

 Minimum 2 years' experience in a regulatory role

 Hands-on working knowledge of domestic FDA OTC drug product requirements

 Experience with FDA inspections

 Strong knowledge of cGMPs

 Experience with REACH law and WERCs

 Experience writing SOPs

 Understand MoCRA requirements

 Excellent oral and written skills

 Open, honest communication skills

 Statistical Evaluation of data

 Strong computer skills utilizing a Microsoft environment (Word, Excel, Access, Power Point)

 Utilizes a database and other digital files to create reports and dossiers.

 Reasoning Ability:

 Has the ability to define problems, collect data, establish facts, and draw valid

conclusions in any situation

 Has the ability to solve problems and deal with a variety of variables in situations where

only limited information exists