Senior Specialist, Regulatory Affairs

Job Description

The Position

The Senior Specialist is responsible for all RA submission requirements and activities for their assigned product portfolio as applicable. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations. The Specialist is also responsible for other activities (as delegated/assigned by their manager). Acts a Poison License A Holder for the company.

Responsibilities

• Responsible for execution of local RA processes and activities in alignment with RA systems and their associated Quality Management System, following department SOPs, company Policies and Procedures and country legislation.

• Assist in development of product registration plans & strategies and working cross-functionally to review & communicate the registration strategy with management oversight.

• Assist in timely preparation, submission of new Marketing Authorization Applications to local Health Authorities, maintenance of authorized products through timely submission of post-market regulatory dossiers, including but not limited to variations, renewal applications and supplemental marketing authorizations in accordance with local regulations and global standards.

• Files, stores and archives safety-related and regulatory data and documentation 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 developing 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.

• Contributes in the maintenance of regulatory licenses including, but not limited to, import, distribution, Medical Device.

• May be assigned to support drug shortage management and regulatory requirements for reporting including collaborating with Quality Assurance 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.

• Maintenance of Poison License A requirements.

Required Education, Experience and Skills

• Must be a Licensed Pharmacist

• Pharmacy degree by education / experience

• Fluent in English (written and spoken) while proficient in local language.

• Minimum of 5 years of industry experience in regulatory affairs.

• General knowledge of RA regulations within his/her assigned country and be an expert in RA processes/activities.

• Good communication and time management skills.

Secondary Job Description

📌 Note:​
There will be an outbound CV screening call from our Talent Attraction Business Partner, and the call may come from an overseas number.
Please make sure to answer the international call to proceed with your application.

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: