Regulatory Affairs Associate

2 weeks ago

Makati City, National Capital Region, Philippines Sandoz International GmbH Full time

1. Liaise with the local Health Authorities on matters pertaining to regulatory activities, licenses and permit.

2. Represent the department in regulatory, safety, quality, PPL, Portfolio and Launch-related meetings in the absence of molecule managers and cross-functional meetings, where regulatory input is required

3. Attends to different conventions/seminars/meetings with regards to the policies and regulations on drug products

Drug Regulatory Affairs

1. Support in the oversight of Sandoz Philippines Corp. compliance to all local regulatory rules and regulations to maintain a legal business.

2. Assist Molecule Managers in the preparation and submission of FDA applications: Renewals, GMP Clearances, Batch Notification, Core Data Sheet Updates, Product Safety Updates, Risk Management Plan, Post Approval Commitment, Minor and Major Variations.

3. Performs Regulatory-related administrative tasks which includes and may not be limited to the following: Check preparation, Notarial activities, FDA check payment and monitoring, management and organization of RA files and databases.

4. Prepares registration reports to the Head of Drug Regulatory

Affairs and Molecule Managers.

5. Provide responses to FDA as per direction from Head of DRA and molecule managers,for the purposes of gaining regulatory advantage and outcomes during the evaluation process e.g fulfillment of new FDA guideline, submission of post approval commitments and compliance to deficiency letters.

6. Support other internal Functions: Legal, Finance, Sales and Marketing, Strategic Alliance, Medical, QA and SCM in providing RA-related information and documentation.

7. Facilitates compliance with additional regulatory requirements to support Sales and Marketing e.g. inclusion of products in connection to the hospital formulary and PNDF.

4. Keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment (especially CLIDP regulations), and communicate appropriately to involved or affected parties.

5. Build functional partnership and credibility to maximize regulatory value in support of business decisions.

Artwork Management

1. Responsible for preparation and maintenance or regulatory compliant, competitive and up-to-date core labelling documents and artwork management for assigned marketed products throughout the product life cycle in accordance with Sandoz policies and procedures.

a. accuracy and correctness of AWs

monitoring the progress of the AWs of products

b. ensuring that there is no delay in launch and supply due to AW-related issues

c. managing the work assignment of AW of the responsible person

d. revising safety information due to updates in the CDS to the graphic artist to ensure 100% compliance to FDA-approved product insert

e. managing the resolution of AW-related issues of all Sandoz products in collaboration with other internal stakeholders

f. improvising AW development process, when necessary.

1. Supervise and/or monitor PSUR and RMP submissions to HA according to regulatory requirements 2. Ensures recording and tracking of receipts/submissions of Periodic Safety Report Updates (PSUR) and ensure reporting/submission of safety reports/updates/information to local Health Authorities (HA) according to regulatory requirements.

3. If applicable, coordinates Risk Management Plans/Commitments and ensure related documentation.

Compliance

1. Compliance to global/local internal processes and procedures including marketing codes including Integrity and Compliance Framework

2. Compliance to local laws (e.g. DOH, FDA regulations and AOs)

3. Completion of e-learning courses

4. Good Regulatory Practice

5. Ensure awareness and understanding of the Sandoz Code of Ethics and other integrity and compliance guidelines and policies (Speak-up Office, Anti-Bribery, Conflicts of Interests, P3, etc.)

6. Adhere to the highest ethical standards in the industry and abide by the Sandoz Code of Ethics and other integrity and compliance guidelines and policies (Speak-up Office, Anti-Bribery, Conflicts of Interests, P3, etc.)

7. Report potential misconduct violations to the Code of Conduct and other integrity and compliance guidelines to the Compliance Officer, P&O, Speak-up Office

8. Ensure attendance and understanding of the mandatory and corporate trainings, i.e. Compliance and Code of Ethics Training, P3, Adverse Event Reporting, ER Process, Sourcing Proce-dure, Travel and Expense Guidelines.

Key performance indicators:

Timely, accurate and correct submission of regulatory registration application upon receipt of dossiers/documents as per agreed timelines

Timely, accurate and correct maintenance of Regulatory files and databases

Compliance to local regulations e.g. Health and FDA administrative orders

Education:

Bachelor of Science in Pharmacy, duly licensed by the Professional Regulation Commission; Duly accredited Qualified Person for Regulatory Affairs (QPIRA)

Work Experience:

With background in Regulatory Affairs (1-2 years preferably)

Computer proficiency in a word processing and database program, good verbal and written communication and presentation skills in English, interpersonal and negotiation skills,

Knowledgeable with the Administrative Orders and Circulars of the Food and Drug Administration

Cross Cultural Experience.

Skills:

Detail Oriented.

Labeling Documentation (Knowledge in Adobe Arobat and Adobe Illustrator)

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