Product Regulatory Affairs work includes: •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. Applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: • Work is closely supervised. • Problems faced are not typically difficult or complex. • Explains facts, policies and practices related to job area. **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 search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. **Already a Convatec employee?** **If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!**