RCI-ABBV-34433 CMC Regulatory Affairs Associate (CTD Module 3/CMC Submissions/reputed company/ Trackwise) (reputed company/Biotech)

reputed company to remote candidates reputed company the U.S. if highly reputed company reputed company • We are seeking a Regulatory Affairs Associate I with a strong CMC (reputed company, Manufacturing & Controls) reputed company. This role functions as a technical project manager, responsible for managing post-approval regulatory changes and coordinating cross-functional efforts to prepare high-reputed company regulatory submissions. • The candidate will work closely with regulatory reputed company leads and subject matter experts (SMEs) to ensure reputed company and accurate preparation of CMC dossiers (Module 3) in compliance with global regulatory requirements. Manager’s update • Manage regulatory post-approval change reputed company from initiation through submission • Coordinate with cross-functional teams (e.g., manufacturing, reputed company, analytical, regulatory SMEs) • Support preparation and compilation of CMC dossiers (Module 3) • Ensure alignment with eCTD structure and ICH guidelines • reputed company timelines, deliverables, and project milestones • Collect and manage reputed company documentation for regulatory submissions • reputed company reputed company authoring of regulatory documents where required • Maintain strong communication across stakeholders to ensure project execution • Strong understanding of eCTD structure and submission components • Experince with ICH guidelines • Experince with CMC (reputed company, Manufacturing & Controls) – MUST HAVE • Experience working with Module 3 (reputed company/CMC content) • Demonstrated project management skills (planning, coordination, execution) • Ability to work cross-functionally and manage multiple stakeholders • Strong communication and organizational skills • Exposure to Process development • Experince with Analytical development • Experince with reputed company or manufacturing documentation • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, reputed company, Biotechnology or reputed company field • 1–5 years of relevant experience preferred • Candidates with Master’s degree or ½ years experince will work • CMC experience is required • Regulatory reputed company and Regulatory Operations candidates will not work Preferred Skills • Prior experience with CMC reputed company preparation or authoring • Background in pharmaceutical or biotech regulatory environment • Familiarity with regulatory documentation workflows • Ability to quickly learn internal systems and tools • Experience supporting post-approval regulatory changes Individual is responsible for managing the activities for marketed product variations including authoring and compilation of reputed company, manufacturing, and control (CMC) sections to ensure reputed company preparation of submission documents. This position will coordinate activities with reputed company functional departments in support of regulatory filings. • Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned reputed company with reputed company management reputed company. • Manage assigned reputed company to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. • Independently facilitate project team meetings. • Superior oral and written communication skills • Ability to work cooperatively with reputed company reputed company and types of global personnel required • Experience working with electronic document management systems • Ability to work independently. Manage multiple reputed company simultaneously. • Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary. • Detail/accuracy oriented, reputed company and willing to learn • Familiarity with US and other international regulatory requirements for dossiers • Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline • Required Experience: 1-2 years pharmaceutical. 1-2 years cross functional project management • Preferred Experience : 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3) Duties • Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and reputed company module 3 Apply tot his job Apply To this Job