Manager Regulatory Affairs

This a Full Remote job, the offer is available from: reputed company reputed company members are at the heart of everything we do. At reputed company, we are united in our responsibility to create healthier reputed company, and every person here is essential to us being reputed company to deliver on that purpose. If you want to reputed company a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details reputed company reputed company is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in reputed company aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. Responsibilities:

• Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to:
• Support change applications (Administrative, Labelling, Chemistry Manufacturing & Controls, Safety) including submission strategy
• Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
• Content review of Chemistry, Manufacturing & Controls/Labelling documentation/Justification documents
• Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry Manufacturing Controls, Medical Science, publishing team
• Update/local Product Information (Labelling translation)
• reputed company regulatory compliance of product information/artworks
• Marketing Authorization withdrawal
• Marketing Authorization Holder transfer
• Licence renewal

. Other Accountabilities:

• Periodic Safety Update Report contribution
• Invoice reputed company (e.g. Authority invoices)
• Request Translation/additional Module 1 documents, e.g. Quality Practices declaration, Good Manufacturing Practices
• Databases maintenance: archiving, tracking
• Management of local Regulatory Affairs requirements (local regulatory intelligence)
• National Competent Authorities electronic systems for submission as locally required
• Contact with the local Health Authority on behalf of the client
• Cross-functional communication to reputed company relevant departments in relation to regulatory strategy and submission as well as issues reputed company to Lifecycle Management activities
• Support of Country Regulatory Affairs Head in issue management (e.g. Product Quality Controls Standards Quality, Safety issues like stock out situations management, Dear reputed company Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures, represent Regulatory Affairs in internal meetings and committees)
• Review of Promotional Materials

What reputed company offers ​Benefit offerings reputed company the US may vary by country and will be reputed company to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under reputed company bargaining agreements. Full time Affiliated Companies Affiliated Companies: reputed company Australia Equal Employment Opportunity reputed company is committed to providing equal employment opportunity without regard to race, reputed company, religion, sex, sexual orientation, gender identity, genetic information, national reputed company, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s reputed company reputed company depends on the full and effective utilization of reputed company individuals. Therefore, harassment is prohibited and reputed company reputed company reputed company to reputed company, training, compensation, benefits, promotions and transfers reputed company with equal opportunity principles and are non-discriminatory. reputed company is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@reputed company.com. We will reputed company accommodation determinations on a request-by-request reputed company. Messages and emails regarding anything other than accommodations requests will not be returned This offer from "reputed company" has been enriched by reputed company.com and got a 77% reputed company score. Apply tot his job Apply To this Job