The Regulatory Affairs Senior Specialist coordinates the regulatory activities for development projects including new products and life cycle management. This includes assisting with regulatory strategies and timelines as well as the development and implementation of submissions under the direction of a line manager
Essential Duties and Responsibilities
Regulatory Support for Project/Product Teams: Provide ongoing support to cross functional teams to provide regulatory strategies during product development. Identify and assess regulatory risks and project issues. Make recommendations to team and regulatory management. Provide regulatory timelines to coordinate with department and corporate objectives.
Regulatory Submissions: Interact with project team members to ensure high quality and timely regulatory submissions. Preparation and coordination of submissions in accordance with the current regulations and guidance’s. Ensure submissions support company objectives and strategy.
Communication with Regulatory Authorities: Interact with regulatory health agencies, contract manufacturers, affiliates and distributors as necessary. Document and archive these discussions and communicate discussions with internal stakeholders as necessary.
Regulatory Intelligence: Maintain current regulatory knowledge of regulations and guidelines related to company’s activities and products. Communicate to internal stakeholders the interpretation and implications of regulations and guidance as necessary.
Labeling: Review and provide strategic regulatory input on product and package labeling as needed.
Further Tasks: Provide support to other regulatory staff as needed and performs duties and assignments as required. Communicate and raise questions/issues to the attention of regulatory management. Additional duties as needed to support the business and overall company objectives.
Job Related Qualifications/Skills
Required Professional experience:
Minimum 5 years of relevant regulatory experience
Required Knowledge, Skills, and Abilities:
Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
Demonstrated success in assisting with the preparing, filing and completing of regulatory submissions
Required Education:
Bachelor's degree in scientific or healthcare discipline
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
