Senior Manager RAPI

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.

Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our new Sandoz!

Position Purpose:
Lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for active ingredients/intermediates.

• Under supervision, formulate and lead global regulatory strategy with a focus on maximizing the business benefit balanced with regulatory compliance for drug substances under own responsibility.
  Responsibility for innovative solutions and independent deduction and management of more complex activities for gaining and maintaining the activities according to the legislation, guidelines, good practice and business goals.
• Professional and timely planning / authoring / reviewing / coordination / submission of regulatory CMC documents in cooperation with relevant stockholders
  a. Compilation of drug master files and/or dossier parts and/or submission package applying agreed regulatory strategies and current regulatory trends during development, registration and product lifecycle. Ensuring technical congruency and regulatory compliance, meeting agreed upon timelines.
  b. Submission of dossiers to the respective Health Authorities in line with applicable guidelines and align strategies.
  c. Processing of CMC documentation related customer inquiries in cooperation with adequate stakeholders during development, registration and product lifecycle
  d. Prepare CMC responses to health authority questions during development, registration and product lifecycle
  e. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may affect submission quality or timelines, as early as possible.
  f. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  g. Review regulatory CMC documents if sufficient level of information enabling Sandoz as MA holder to take full responsibility for the quality of the medical products and quality control of the active substances including control of mutagenic impurities as per ICH M7 guidelines. Review if sufficient information on the manufacturing and control is given, and starting material designation is performed in line with requirement of the ICH Q11 guidelines and ICH Q11 Q&A documents. Compile technical assessment in line with Sandoz procedure including identify gaps and follow up with relevant tack holders.
• Generation and/or review internal regulatory guidance documents and SOPs within assigned projects
  Establish and maintain sound working relationships with colleges, partners and customers. Provide regulatory guidance to cross-functional teams, and determine regulator impact for changes in chemistry, manufacturing, and control procedures. Support or/and lead global regulatory projects/initiatives.
• Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends. Responsibility for transfer of knowledge and experiences to the organization.
• Supervise and develop regulatory manager and associate manager registration for assigned projects
  Establish yourself and/or be a topic lead under minor supervisor for agreed subject this involves guide related discussions, provide insights. Dive deep into the topic to understand all its facts, keep abreast of the latest developments and trends.
• Work according to internal and external guidance s, SOPs and respective timelines.

What you ll bring to the role: Essential Requirements:

• PhD (natural science: chemistry, pharmacy, biology or related substances) with min 6+ years work related post-doctoral / industrial experience or Master/BSc (natural science: chemistry, pharmacy, biology or related substances) with at least 3 years of work-related experience including people management experience
• Leadership experience within regulatory affairs function:
  1) Broad knowledge on Module 3
  2) Broad knowledge of regulatory guidelines
  3) Good knowledge of relevant software tools
  4) Good skills in presentation and scientific/technical writing
  5) Good documentation skills and able to understand and exactly follow written procedures

Why Sandoz? Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management