Advisor​/Senior Advisor Global Regulatory Affairs CMC – Post Approval – Synthetic Molecule Drug

Advisor/Senior Advisor Global Regulatory Affairs CMC – Post Approval – Synthetic Molecule Drug

Join to apply for the Advisor/Senior Advisor Global Regulatory Affairs CMC – Post Approval – Synthetic Molecule Drug role at Bio Space.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life‑changing medicines to those who need them, improve understanding and management of disease, and give back to our communities through philanthropy and volunteerism. It’s our purpose to create medicines that make life better for people worldwide.

Lilly is looking for post‑approval regulatory CMC scientists to join us in delivering life‑changing new medicines to patients around the world.

The Advisor Post‑Approval Scientist in Global Regulatory Affairs – CMC Commercial Products will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post‑approval and lifecycle regulatory strategies and submissions for Lilly’s commercial products. The regulatory scientist will demonstrate innovative regulatory strategies that support the lifecycle of the assigned product(s).

• Deep technical knowledge of synthetic molecule drug substance CMC science and manufacturing processes for conventional small molecules and/or synthetic peptides, proteins or oligonucleotide.
• Knowledge of global CMC regulatory requirements and guidelines for reporting post‑approval changes and updating global product registrations.
• Develops and evaluates global CMC regulatory strategies in collaboration with regulatory, manufacturing, quality and project personnel to enable timely completion of submission milestones leading to health authoring approval.
• Develop regulatory strategy and update strategy based upon global regulatory changes.
• Provide regulatory guidance to allow CMC teams to make informed decisions on global registrations and product lifecycle planning.
• Anticipate and resolve key technical or operational issues that could impact the function, CMC team and/or submission timing.
• Takes on and independently manages challenging projects and identifies creative solutions that support functional and partners organization requirements.
• Takes a proactive leadership role in the critical review of molecule‑specific CMC development strategies and submission content for registration, post‑approval changes, line extensions or renewals, and responses to questions.
• Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.

• B.S. degree in science, engineering, or a related field. Fields of study include Chemistry, Pharmacy or Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, Biochemistry, or similar.
• 7+ years of regulatory CMC or technical CMC experience in synthetic molecule drug substance development, commercialization or manufacturing.

• Demonstrated deep technical knowledge and experience of synthetic molecule drug substance development, commercialization and manufacturing processes, including conventional small molecules and/or synthetic peptides, proteins or oligonucleotides.
• Prior regulatory CMC experience supporting commercialization and/or post‑approval submissions for synthetic drug substances, or equivalent combination of technical and regulatory guidance knowledge.
• Knowledge of major market procedures, regulations, and practices. Awareness of evolving global regulatory initiatives desirable.
• Experience planning for and/or participating in Health Authority meetings.
• Demonstrated ability to assess and handle risk in a highly regulated environment.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated leadership behaviors and negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated teamwork skills; able to adapt to diverse interpersonal styles.

• Position Location:
  
  Indianapolis, IN. A remote option is not…