Senior Specialist, Regulatory Affairs

Job Description

The Position:

This role will provide support across Regulatory Operations activities in the EU/EMEA, US, LATAM, Canada (Americas) and APAC regions spanning across submission planning. The role will be a contact for management across key functional areas for the delivery of timely and high-quality submissions from planning through to delivery at Country RA or submission to the authorities. It will be important for this role to be a conduit of information between the broader Global Reg Ops Regional Teams (LATAM and APAC, in addition to Americas and EU/EMEA) to the Regional (Product Registration) Regulatory Teams. There is also an expectation to coordinate with other R&D leads (e.g. PV Ops, Label Ops, Regulatory Business Systems/Business Technology, Business Development & Vendor Management, Portfolio & Program Management) and Manufacturing/CMC. A key focus will be providing leadership, support, and subject matter expertise (SME) to partner planners and publishers. This position will report to the Director of Global Submission Operations within Regulatory Affairs Operations in the Research and Development organization of Organon & Co.

Responsibilities (will span Submission Planning Capabilities):

Submission Planning-specific:

• Actively manages submission timelines and has a clear understanding of dependencies and critical path activities

•  For assigned products, works closely with the Regulatory Lead to assess the overall program and manages the sequencing of submissions as needed

• Facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant stakeholders

 General:

• Independently identify, assess, and actively resolve or escalate where necessary any risks or issues that could impact the successful completion of regulatory submissions

• Ensures project data, including information used to maintain compliance and aid with submission planning, is accurately reported in databases

• Support the development of processes and documentation, including user acceptance testing for new and updated tools. Delegation of these project activities to planners/publishers within the department as needed.

• Assume the role of subject matter expert for specific functions or processes, interacting and mentoring both within the department and with external stakeholders

• Support training/mentoring internal and external staff.

Required Education, Experience, and Skills

Skills/Qualifications:

• Must have proven track record to be able to think critically, strategically, independently and problem solve

• Must have high level of motivation, drive, and demonstration of Organon leadership values

•  Excellent written and verbal communication skills including ability to write clearly and concisely

• Top notch interpersonal skills in difficult situations

• Driver of change and innovation

• Ability to work seamlessly with all levels within the organization

• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations

• Experience with SharePoint, Excel, e-mail, and online meeting tool skills.

Experience:

• In depth working knowledge of industry standard publishing systems and desktop applications including MS Word and Adobe Acrobat Professional

• Preferred Experience:

  • Experience with the Liquent In-Sight Publisher application

  • Experience with industry standard electronic document management system

  •  Experience with project management and leading teams

Education:

• Required: Bachelor’s degree and at least five years overall work experience with at least 3 years of regulatory operations experience

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: