The International Regulatory & Documentation Specialist is appointed by the Vice President, Product Development & Quality and is solely responsible to him/her for an interim period. Upon the completion of the interim period, the International Regulatory & Documentation Specialist will be solely responsible to the Supervisor, Regulatory Affairs. The International Regulatory & Documentation Specialist is responsible for preparing, reviewing, and gathering regulatory documents necessary for international product registrations (new and existing, excluding US and Canada) and related regulatory affairs activities, including consulting with local (country specific) regulatory resources to ensure product and company compliance to applicable regulatory requirements.
ESSENTIAL JOB FUNCTIONS
- Acts as the point of contact for International distributors regulatory groups and international consultants to support regional registration requirements and addresses any present and future regulatory concerns, inquiries, and complaints about the products and their ingredients.
- Plans, coordinates, and prepares International regulatory submissions of various types, including, but not limited to, EU, Asia, Australia, and Latin America technical documentation, international dossiers and registration filings.
- Communicates International registration requirements to Vice President, Product Development & Quality, the Supervisor, Regulatory Affairs, Quality, and the Product Development team.
- Monitors International regulatory activities (via International market specific consulting groups, distributors’ regulatory groups, and other government communication vehicles) and proactively presents, advises, and executes internal programs associated with these activities.
- Works closely with Research & Development, Purchasing, Quality Assurance, and Quality Control to obtain all documents and test data necessary to comply with regulations in International markets such as product safety, purity, efficacy, and claims substantiation requirements.
- Attends monthly International Product Development team meetings and provides Regulatory inputs’ while keeping management informed.
- Coordinates timely preparation of requests for Certificates to Foreign Governments, Certificates of Pharmaceutical Product, Certificates of Manufacture and Free Sale. Interfacing with applicable regulatory agencies and international consulates on these matters.
- When there are product changes:
- Communicates changes to International distributors’ regulatory groups to properly assess proposed change implications and impact based on local regulations.
- Upon receipt of these assessments communicates to management and internal customers (International Marketing, International Operations, R&D, and Quality) product change assessments per International markets to obtain alignment and coordinates the necessary activities to successfully implement the proposed changes in the individual International markets.
- Prepares and manages EU dossiers to support product registrations of EU products. Assembles, technical product information necessary to the EU Safety Assessor to perform Product Safety Assessments.
- When necessary, reviews and evaluates product labeling to ensure compliance with the International market regulations and requirements.
- Maintains contracts with International market specific consulting groups.
- Acts as the principal department contact for handling, planning, and responding to International regulatory inquiries and requests from internal customers.
- Periodically audits International product packaging and labeling for adherence to company standards.
- Periodically monitors International distributors’ websites and social media for adherence to company standards.
- Develops and implements creative regulatory strategies, approval schedules, and submission standards to achieve department and organization objectives.
- Develops and maintains departmental procedures (SOP's) for international product registrations and activities.
- Participates in facility audits and on issue-specific committees, as required by the Supervisor, Regulatory Affairs.
- Performs and assumes other duties and responsibilities, as may be required by the Supervisor, Regulatory Affairs.
- Supports the Winner’s Circle and Quality System processes.
|EDUCATION AND EXPERIENCE
- A 4-year technical college degree in a specialized field such as science or technology; or equivalent in knowledge and training.
- The knowledge and skills required for this position are typically acquired in 4 to 5 years of experience in a pharmaceutical and/or OTC regulatory environment.
SKILLS AND ABILITIES
- Attention to detail and ability to work well under pressure.
- Effective interpersonal skills to interact with various levels of internal and external customers.
- Good oral and written communication skills in business English (spelling, grammar, and punctuation).
- Computer literacy in a Windows environment (Word, Excel, and Outlook).
- Ability to prepare detailed and accurate documentation.
- Familiarity with International Cosmetics and Sunscreens regulations as they relate to FDA OTC regulated drug products.
- Working knowledge of Current Good Manufacturing Practices (cGMP).
- Strong organizational and analytical abilities.
- Ability to work independently and meet deadlines on a multitude of concurrent tasks.
- Willingness to accept other duties, as assigned.
- Discretion with confidential information.
- Ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management, and comply with Company policies.