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)

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This job is with Organon, an inclusive employer and a member of my
Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Job Description

The function

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
- 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.

The successful candidate will act as the key CMC point of contact and Subject Matter Expert for CMC issues within the region. He/she will engage with Country RA, HQ CMC, Manufacturing, Supply Chain and Commercial teams, to ensure that CMC regulatory issues in the region are appropriately understood, communicated, prioritized and managed. He/she will work closely with CMC Product Leads and CMC Franchise Leads to ensure that Organon's key CMC projects are successfully prosecuted in the region.

In addition, the Director will represent Organon in relevant trade associations and other forums and play a role in developing and communicating policy priorities internally and externally.

This role will manage a team of individual contributors and/or outsourced staff.

Responsibilities

• Act as liaison between Organon's HQ CMC organization and the Country and Regional Regulatory Affairs organizations.
• Interpret major regulatory developments in the region, conduct impact assessments and define 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
  - approval changes for the region.
• Contribute to critical submission strategies with CMC Product Leads and CMC Franchise Leads, authoring submission components, change control assessments, HA meeting background packages, and other regulatory CMC activities for existing portfolio and new product development/biz dev & licensing activity.
• Align on CMC priorities for the region, via consultation and agreement with Franchise leadership, Regional / Country regulatory affairs, HQ CMC and other stakeholders as appropriate.
• Plan and
  - ordinate at a high level major regional CMC submission projects that are key to the company's goals.
• Work effectively with other stakeholders (Country Managing Directors, Manufacturing, Supply Chain) to ensure that the company's goals are achieved in compliance with CMC regulatory requirements.
• Resolve
  - hoc CMC requests and issues within the region, acting as point of escalation where appropriate.
• Support and attend Health Authority meetings and discussions within the region, liaising with EMA and other international Health Authorities for Regulatory CMC and related topics (e. g. , inspections, investigations).
• Develop CMC and related policy positions and advocate on behalf of Organon through industry associations or directly with Health Authorities.
• Hold HR and line management responsibilities for i
  CMC Strategists, manage performance and ensure objectives are met by each individual contributor.

Required Education, Experience, And Skill

• Bachelor’s Degree in a science, engineering, or related field (Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry) with at least 10 years of relevant experience in biological/pharmaceutical/device research, manufacturing, testing, or a related field. 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
  - phase programs.
• Substantial experience in CMC regulatory affairs for small molecules (Drug substance, multiple drug product dosage forms) is essential. 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 is an advantage.
• A strong business acumen with a good understanding of the priorities and ways of working across commercial, manufacturing and supply chain.
• Demonstrate ability to develop creative and imaginative approaches to problem solving, flexibly respond to changing priorities or unexpected events, define global regulatory CMC strategies, adapt to varied operating models, collaborate, decide strategically, and work well under pressure.
• Excellent written and verbal communication skills. The ideal candidate will be fluent in 1-2 languages spoken in the region, in addition to English.
• Embodies Organon values in
  -
  - day activities and serves as an example by practicing them daily.

Secondary Job Description

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.

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.

Recruiter / Agency Information

Organon LLC does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no
- existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Job Details

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

Seniority level: Director

Employment type: Full-time

Job function: Legal

Industries: Pharmaceutical Manufacturing