Regulatory Affairs Specialist

ROLES & RESPONSIBILITIES

New Product Launching

Actively involved in new product registration and launching, review registration dossier, monitor & performing best approach to registration process, and to provide update to cross-functional team in new product launch plan in order to ensure alignment to company strategy.

Prepare and compile registration dossier for New Drug Application based on company data file or standard in accordance to Indonesia local HA (BPOM) requirement including other components of the registration package and ensure that the dossier is of high quality and accuracy completed in a timely and efficient manner also keep follow up and monitor progress of registration filing to achieve approval within target timeframe.

Product Lifecycle Management

Maintain registration number by on time renewal registration submission by preparing registration dossier in accordance to FDA requirement and follow up registration process to achieve approval within target timeframe.

Follow up all registration changes which come from global and local by preparing dossier registration and on time submission and approval within target timeframe for Labeling Update (Safety and Non-safety) and CMC

Compliance & Regulation

Finding information and analyze about regulatory requirement and updating any new regulation also giving guidance/recommendation/direction based on gathered regulatory information to related parties.

Ensure to be cognizant of, and compliant with, all relevant Indonesian regulatory legislation and guidelines as issued by the Indonesian governments, BPOM, Company Corporate Procedures and Local Country Standard Operating Procedures (SOPs).

Ensure that all regulatory database is 100% updated by providing updating information on time to regional/global.

Ensure and do verification packaging to comply with the regulation, registered and approved specification

To foster an environment that is consistent with the Company core values, ethics and standards

Supporting Cross Functional Team

Conduct regulatory Intelligence by fully aware with what our competitor by finding out important information from other companies through corridor conversation and also through other media (internet, etc.)

Support CFT team for post launching activities by providing required document

Special Assignment

To complete special task/Subject Master Expert that is assigned by Supervisors and Management.

REQUIREMENTS

Critical Skills

Negotiating/Influencing

Communication - verbal and written

Leading People

Strive for excellence

Act for change

Problem Solving

Strategic Thinking

Self-Motivated

Commercial Acumen

Highly Desirable Skills

Biomedical Diseases knowledge

Medical Writing

Knowledge and Experience

Minimum bachelor’s degree in pharmacy or Science majoring in biochemical field.

Familiar with National Food & Drug Administration (Badan Pengawas Obat & Makanan) policies and procedures

Ability to create and maintain a stable and motivating working climate based on trust and co-operation.

Minimum of 6 years of experience, preferably in oncology regulatory

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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.

Employee Status: Regular

Relocation:No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

R291498