Job Description
The Position
The candidate will be a part of Japan Regulatory Affairs (RA) organization and reporting into the Head of Japan Regulatory Affairs.
Responsibilities:
Primary Activities:
Develops new drug regulatory strategy for Japan from early Phase to Life Cycle Management (LCM) activities (i.e.: new indications, line extension, major efficacy variations aligned with regional priorities
Collaborates with commercial and local stakeholders to align regional regulatory strategy with country priorities.
Communicates program information with Country team to facilitate developing local regulatory strategy. Identifies the best possible regulatory strategy options in discussion with the countries for filing and pre-submission requirements/support needed from global teams.
Primary communicator with Regulatory Franchise and Global product strategy team members on key strategic issues (including updated guidelines/requirements) for Japan / regional countries and ensuring any updates are communicated in a timely manner.
Responsible for Labelling activities, such as development and maintenance of local labels, package inserts and Guide for Patients and artwork (AW).
Responsible as a point of contact to local Health Authority (PMDA)
Oversee external service providers.
This position needs communication and teamwork skill with responsible functions in local and global.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Other activities:
Be a SME for RA related system and/or procedures if required
Be a point of contact for RA/ORD related inquiry/communication from local HA and/or hospitals if required
Working in matrix environments including global teams
Required Education, Experience, and Skills:
Bachelor's degree and at least 15 years of pharmaceutical industry experiences including at least 3 years of directly related experience, OR
Master's degree and 10 years of pharmaceutical industry experiences including 3 years of directly related experience.
Thorough, knowledge of regulations pertaining to new drug registration and risk/ safety standards is a pre-requisite.
New Drug Strategy leadership is expected to have strong leadership, communication, decision making, and problem-solving skills.
Willing to perform labeling activities, even without prior experience in this area.
Japanese: Native level, English: Business level
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:
RegularRelocation:
No relocationVISA 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:
1-
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