Job Description
The Position
The RAaPV Senior Specialist is responsible for all aspects of regulatory submissions in the assigned markets. Critical to this role is to combine knowledge of scientific, and regulatory issues to enable new/established products that are developed, manufactured, or distributed meet the local legislations and company procedures. Leveraging on expertise in regional regulations, Authority expectations and industry trends, this role will collaborate closely with cross-functional teams to enhance regulatory initiatives, drive regulatory compliance, and support supply continuity.
The Senior Specialist is responsible for all regulatory submission requirements for their assigned product portfolio as applicable including provide and development of product registration plans & strategies and working cross-functionally to review & communicate the registration strategy with management oversight
The Senior Specialist collaborates with colleagues to ensure compliance with local laws and regulations as well as company SOPs.
Responsibilities
- Assist and support in development of product registration plans & strategies and working cross-functionally to align & communicate the submission plans.
- Support maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, GMP clearance, renewal applications, site transfers, importation, distribution, tender related activities and supplemental marketing authorizations in accordance with local regulations and global standards.
- Maintain and archive regulatory documents in accordance with department and company policies and local requirements.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Assists in improving local procedures (in compliance with regional and global standards) for the department, to ensure quality RA data and evaluates processes for potential improvement in efficiency and effectiveness.
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Quality and supply chain to avoid supply constraints and ensure constant audit-readiness.
- As delegated, ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply-chain.
- Support the deputy/back-up Qualified Person for PV (QPPV) / Local Responsible PV person as required per local PV legislation and will be responsible for supporting local PV activities as assigned.
- Coordinate and oversee regulatory activities across the cluster/region for assigned projects.
- Where applicable, contribute as representative in regulatory associations working groups and/or other regulatory projects from time to time with supervision from manager.
Task
- Technical change management including dossier preparation and compilation
- Label updates and artwork maintenance
- Agency requests with post-marketing samples
- Documentation and archiving of dossiers
- Maintenance of internal regulatory systems
- Support PV activities as assigned and work collaboration with LPVR and Regional PV unit
Competencies
- Inspires growth: Identifies and analyzes business needs in terms of capabilities, skills, behaviors, and mindsets needed. Demonstrates advanced skills to drive change and champions development.
- Delivers with accountability: Aligns strategic priorities to team priorities and team resources and delivers results in accordance with timelines and appropriate regulations. Monitor regulatory trends, drives compliance, and proactively manages and mitigates risks to achieve quality outcomes.
- Innovates with agility: Encourages diverse thinking and experiments with new ways of working. Demonstrates advance skills in problem solving using creative thinking, aligning with stakeholders to responds to new, complex, or problematic situations.
- Makes connections: Ability to work in partnership with others (internally and externally) to accomplish quality goals; leads integrated projects and build effective networks.
- Communicates with optimism and authenticity: Articulates a compelling shared vision and communicates with empathy. Demonstrates advanced oral and written communications and presentation skills. Makes timely and appropriate decisions and to determine when escalation of issues is necessary.
- Activates belonging: Reinforces diverse representation and consideration in all talent selection and development activities across teams.
Required Education, Experience And Skills
- The incumbent must have bachelor's degree in pharmacy / pharmaceutical sciences, a health, life science, or medical science degree or equivalent by education / experience and be fluent in English (written and spoken).
- Minimum of 5 years of industry experience in regulatory affairs and/or CMC.
- Expert knowledge, understanding, and application of principles, concepts, and practice of regulations in the assigned market. ASEAN regulations is a plus. Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio
- Excellent communication and time management skills, the ability to interface broadly with colleagues within related functions and cross-functionally and be able to work independently across markets.
- Actively responsible, well organized and able to work as team with positive attitude and open-minded.
- Ability to effectively negotiate and influence management, affiliates, regulatory agencies, and industry to ensure that regulatory and business needs are met.
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
Regular
Relocation:
No relocation
VISA Sponsorship
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Shift
Flexible Work Arrangements:
Valid Driving License
Hazardous Material(s):
Number Of Openings
1
Requisition ID:R529435
