RA manager, TW&HK

About the role

In this role, you'll play a key part in working alongside a dynamic team that values innovation, collaboration, and continuous growth. Your key responsibilities will include: -Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports -Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies -Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions -Serving as a regulatory liaison on the project team throughout the product lifecycle -Participating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC) -Ensuring pre-clinical and clinical trial designs meet regulatory requirements -Ensuring rapid and timely approval of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices -Serving as regulatory representative to marketing or research project teams and government regulatory agencies -Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations -Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices. About You To be successful you will: - Managing projects / processes, working independently with limited supervision. - Coaching and reviewing the work of lower level professionals. - Problems faced are difficult and sometimes complex. Education/Qualifications Minimum educational requirements if applicable (for example Degree, industry qualifications, etc) Industry memberships / Professional Registrations What You'll Get At Convatec we believe in taking care of our people, because they're the heart of everything we do . As part of our team, you'll enjoy a range of benefits designed to support your wellbeing, growth, and success. These include Flexible working arrangements, Ongoing learning and development opportunities Competitive remuneration Access to health and wellbeing programs Ready to join us? At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life. #LI-EZ1 #LI-Onsite Beware of scams online or from individuals claiming to represent Convatec A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address. If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you're unsure, please contact us at careers@Convatec.com . Equal opportunities Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law. Notice to Agency and Search Firm Representatives Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed sea