I'm hiring a remote Senior CMC DossierManager - you'll lead the charge in crafting the technical eCTD sections essential for ground breaking initiatives.
Under minimal supervision, you'll take ownership of coordinating and overseeing the generation of CMC dossiers for both marketing and clinical trial submissions.
With your expertise in CMC regulatory applications, you'll drive compliance, accuracy, and timeliness, ensuring submissions exceed regulatory expectations.
Embrace the opportunity to make a tangible impact and elevate your career, at the forefront of innovation in biotech.
You will take the lead, as appropriate, in authoring/driving sections of the CMC dossier and ensure that final versions comply with regulatory standards and meet the expectations of regulatory agencies, all while operating with limited managerial guidance.
Furthermore, you (CMC DossierManager) will support technical functions by developing responses to health authority enquiries for clinical trials and major applications, again with minimal managerial oversight.
You will meticulously evaluate and ensure the completeness, accuracy, and compliance of data for all regulatory submissions.
Timely completion of all Quality submissions is also within your purview.
Requirements Background in technicaldossier development, writing, and biologics.
Experience in intricate markets Asia, LATAM, China, and Russia 8 years of postdoctoral experience University degree plus 10 years of relevant work Responsibilities Contributed at the functional level and to the formulation of complex product development plans and dossier strategies at the compound level.
Demonstrates a high degree of autonomy and accountability in communicating and carrying out the dossier strategy and product development plan.
With little to no manager direction, leads and oversees dossier authoring operations for both early and late-stage projects.
Identifies areas for business improvement and assists in advancing their implementation under the manager's regular supervision.
With management support, develops process and business enhancements within own functional organisation and, if needed, aligns with other departments.
Interacts directly with members of the CMC/Tech team, regulatory authorities, outside service providers, and internal stakeholders with little to no instruction.
Communication with functional stakeholders, both internal and external.
Persuades or influences people to embrace new theories, methods, or concepts or achieves consensus on conflicting problems in the absence of clear direction.
Integrates technical know-how with collaborative abilities.
Oversees several intricate initiatives with the possibility of an accelerated or conventional priority OR directs intricate programmes.
Disrupts the existing quo and can help find creative ways to make products or processes better.
Scope combines transformative and incremental innovation.
Handles cross-functional problems without assistance.
Follows regular instructions, correctly identifies, and manages important stakeholders, and escalates issues as necessary.
Works independently every day, checking in with the supervisor when necessary regarding topics that have been highlighted as high priorities.
Serves as a mentor for one or more people.
Mentor project groups.
Apply today gjohnstonebarringtonjames.com 441293778666 BarringtonJames France Expérience souhaitée
