Director, Regulatory Affairs

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 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.

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 

 Typical responsibilities of the role will include: 

 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 iCMC Strategists. Manages performance and ensures that objectives are being met by each individual contributor.  

Required Education, Experience, and Skill

• Bachelor's Degree, in a science, engineering, or a related field.   Fields of study include Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or 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., PharmD) with at least 5 years of relevant experience including biological/pharmaceutical/device research, manufacturing, testing or a related field
• 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 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. 
• The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.  He/she must have a depth of experience in defining global regulatory CMC strategies, ability to adapt to varied operating models, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.   
• Excellent written and verbal communication skills. The ideal candidate will be fluent in 1-2 languages spoken in the region of responsibility, in addition to English. 
• He/she will be expected to embody Organon values in their day-to-day activities and serve as an example by practicing them daily.   

 OCMC

Secondary Job Description

Who We Are:

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. 

Search Firm Representatives Please Read Carefully 
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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: