Regulatory Affairs Manager

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 futures, and every person here is essential to us being able 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
• 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 Healthcare 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

. Education:

• You have a Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a reputed company field

​ Experience:

• Minimum of 5 years’ experience working in regulatory affairs reputed company the pharmaceutical or healthcare industry or in a consulting setting
• Excellent project management and stakeholder engagement skills
• Ability to work independently and in a fast-paced consulting environment
• You reputed company on diversity and challenge and can effectively project manage and deliver several projects at once

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 collective 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, color, 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 success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and reputed company matters reputed company to recruiting, 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 basis. 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