Director, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC) Lisboa

Director, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC)
Lisboa
Lisboa, Lisboa, Portugal

Director, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC)

Join to apply for the Director, Regulatory Affairs - Chemistry Manufacturing & Controls (CMC) role at Organon Northwest Europe

Overview

Reporting to the Executive Director, Global Operations within REG CMC, the successful candidate will act as the Organon CMC lead for the European (EU and non‑EU), East Europe, Middle East and Africa regions. The International CMC organization will be responsible for establishing, managing and embedding regional regulatory CMC expertise across the entire Organon portfolio of small molecule, biologic and biosimilars, and serving as a regional leader, representing the Organon Regulatory CMC organization.

Responsibilities

• Acting as liaison between Organon’s HQ CMC organization and the Country and Regional Regulatory Affairs organizations.
• Interpretation of major regulatory developments in the region, conducting impact assessments and defining implementation plans as required for broader dissemination within CMC and the wider organization.
• Collaborate with Reg CMC leadership to define, coordinate and enable approaches for optimal change impact assessment for post‑approval changes for the region.
• When required for priority projects, contribute with CMC Product Leads and CMC Franchise Leads in the development and execution of critical submission strategies, submission components authoring, change control assessments, HA meeting background packages, and other regulatory CMC activities as required for the existing portfolio and new product development / business development & licensing activity in Organon.
• Alignment on CMC priorities for the region, via consultation and agreement with Franchise leadership, Regional / Country regulatory affairs, HQ CMC and other stakeholders as appropriate.
• Planning and co‑ordination (at a high level) of major regional CMC submission projects that are key to the company’s goals.
• Working effectively with other stakeholders (Country Managing Directors, Manufacturing, Supply Chain), to ensure that the company’s goals are effectively and efficiently achieved in compliance with CMC regulatory requirements.
• Resolution of ad‑hoc CMC requests and issues within the region, acting as point of escalation where appropriate.
• Supporting and attending Health Authority meetings and discussions within the region and liaising with EMA and other international Health Authorities where necessary for Regulatory CMC and related topics (e. g. inspections, investigations).
• Development of CMC and related policy positions and advocating on behalf of Organon through industry associations or directly with Health Authorities.
• Holds HR and line management responsibilities for i
  CMC Strategists. Manages performance and ensures that objectives are being met by each individual contributor.

Qualifications

• Bachelor’s Degree in a science, engineering, or a related field (Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, Biochemistry) with at least 10 years of relevant experience including biological/pharmaceutical/device research, manufacturing, testing, or a related field, OR Advanced degree (MS, MBA, Ph. D. , Pharm
  D) with at least 5 years of relevant experience.
• Minimum 10 years pharmaceutical or related industry experience; 5 years with an advanced degree. Minimum 5 years working in Regulatory CMC, with progressive experience in leading global development‑phase programs.
• Substantial experience in CMC regulatory affairs for small molecules (Drug substance, multiple drug product dosage forms) is an essential requirement. Experience with Biologics, Biosimilars and Medical devices / combination products would be an advantage.
• Ability to work independently and influence within a matrix structure.
• Experience in managing a small team of contractors, outsourcing partners or internal regulatory CMC staff would be an advantage.
• A strong business acumen with a good understanding of the priorities and ways of working across commercial, manufacturing and supply chain.
• Demonstrated ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
• Excellent written and verbal communication skills. Fluent in 1‑2 languages spoken in the region of responsibility, in addition to English.
• Embodies Organon values in daily activities and serves as an example by practicing them daily.

Company Overview

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6. 5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

Equal Opportunity Employer

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Logistics

Employment type: Full‑time | Seniority level: Director | Job function: Legal | Industries: Pharmaceutical Manufacturing | Employee status: Regular | Relocation: No relocation | Visa sponsorship: No | Travel requirements: 10% | Flexible work arrangements: Hybrid | Shift: – | Valid driving license: – | Hazardous material(s): – | Number of openings: 1 | Requisition ID: R