14 Regulatory Documentation jobs in the Philippines

- At least 1 to 2 years of working experience in the related field
- Willing to do field work
- The Regulatory Affairs Specialist shall provide technical support to legal and registration activities of the RA Department in compliance to the regulatory requirements as mandated by specific regulatory agencies.

Work location: Makati
Work Schedule: Business Hours 8AM 5PM Monday to Friday br>Salary range: 22,000-25,000

Job Qualifications:

At least 1 to 2 years of working experience in the related field
Willing to do field work

The Regulatory Affairs Specialist shall provide technical
support to legal and registration activities of the RA br>Department in compliance to the regulatory requirements
as mandated by specific regulatory agencies.

at least 1 to 2 years of
working experience in the
related field
Willing to do field work

Business Hours 8 AM-
5 PM Monday to Friday

22k to 25k



(Marsman)

The Regulatory Affairs Specialist shall provide technical
support to legal and registration activities of the RA br>Department in compliance to the regulatory requirements
as mandated by specific regulatory agencies.

QUALIFICATIONS:
* At least 1 to 2 years of working experience in the related field
* Willing to do field work

SALARY RANGE: 22K - 25K
WORK SCHEDULE: Business Hours 8AM - 5PM Monday to Friday
WORK LOCATION: Makati

NOTE: THIS IS DIRECT HIRE AND NOT UNDER AGENCY

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
**Bold thinking. Bolder actions. We are Medtronic.**
We're a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs and help shape policies that change lives.
Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.
**Responsibilities may include the following and other duties may be assigned.**
+ Execute submission strategy on-time
+ Prepare dossier for regulatory submissions for Global Region
+ Liaise with Operating Unit regulatory affairs and stakeholders to ensure alignment on submission plan
+ Notify manager in a timely manner upon recognition of issues and propose resolution
+ Respond to queries from FDA/MoH
+ Keeps abreast of regulatory procedures and changes.
+ Provide on-time status about projects under their scope and all applicable regulatory activities assigned
+ Lead and prepare RA meetings involving the OU's under their responsibility
+ Database/tracker management
+ Active participation in projects
**Required Knowledge and Experience**
+ Bachelor's Degree in Pharmaceutical Sciences, Biomedical Engineering, or field related experience.
+ At least 2-year regulatory experience in medical devices
+ Experience in document interpretation, queries and workflow skills is an advantage
+ Proficiency in Microsoft tools
+ Excellent communication skills
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position?
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting?is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
JOB SUMMARY
- Responsible for regulatory strategy, submissions and approvals for new product registrations (pharmaceutical and medical device) and life-cycle management of registered products, and ensure regulatory compliance is maintained, for Pharma and Allergan Aesthetics.
- Support business and cross functional teams from regulatory perspective.
- Represent Regulatory Affairs on Affiliate Management Team
- Responsible to maintain local SOPs and ensure compliance with regulations
- Monitor emerging trends regarding industry regulations to determine potential impact on organizational processes.
- Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.
- Responsible for people management (including contractors) for Abbvie Pharma and Allergan Aesthetics portfolio in Philippines, where applicable.
- Hold the pharmacist licence for the company, where applicable.
CORE JOB RESPONSIBILITIES
Product Registration
- Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives and plan. Support expansion of business in terms of new product registrations in Pharma and Allergan Aesthetics.
- Ensure that the regulatory strategy is designed to deliver timely approval with desired labeling.
- Review regulatory documentation and identify/remediate potential gaps.
- Plan and execute regulatory submissions for new products, new indications, renewals and required changes to maintain current registration of all products, in alignment with planned timelines.
- Monitor progress of marketing applications and variations approval.
- Facilitate communication between Area Regulatory lead and the local regulatory authority via the Marketing Authorization Holder (MAH) (external agency).
- Liaise with MAH to negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
- Manage pipeline products regulatory strategy
Business Support
- Work cross-functionally as required to meet business needs.
- Review and provide input and approval on promotional materials, from regulatory perspective.
- Provide regulatory input and support for marketing plans, product launches and other cross functional activities.
- Provide regulatory updates on registration status in commercial database, during S&OP and/or brand team meetings, where applicable.
- Participate in business meetings, where applicable
- Provide regulatory leadership as needed in product in-license/due diligence review, where applicable
- Support local business teams in tenders, hospital listings and any other activities from regulatory perspective, as required.
- Support commercial QA by providing regulatory input where applicable
Processes
- Responsible for request of documents via Abbvie systems.
- Responsible for artwork and label management.
- Maintain global and regional systems and databases to ensure that all relevant regulatory information is updated.
- Ensure proper filing of and maintenance of local documentation as per corporate procedures.
- Lead or participate in projects to streamline regulatory processes to increase productivity.
Compliance, SOPs and Policies
- Maintain good knowledge of relevant regulatory corporate policies and ensure compliance.
- Prepare and maintain local SOPs and policies relevant to Regulatory Affairs to comply with AbbVie global SOPs & policies and Regulatory Authority requirements.
- Ensure adherence to Abbvie SOPs and compliance with regulations.
Regulatory Intelligence
- Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
- Monitor on changes related to the regulations affecting registration, manufacture, distribution and sale & marketing of AbbVie products, and assess its impact on Abbvie's business.
- Communicate changes in a timely manner to relevant stakeholders and management.
- Conduct regulatory risk assessments and mitigation plans.
People/Contractor Management (where applicable)
- Lead and provide guidance to contractor to prioritize and meet target goals and objectives in a timely manner
Qualifications
- Degree in Pharmacy, Biological Sciences, Life Sciences or Pharmaceutical related studies
- Registered and licensed Pharmacist with valid PRC ID is preferred
- Minimum 8 years of regulatory experience in the pharmaceutical industry and/or medical device industry
- In-depth of knowledge of Philippines regulations in pharmaceutical and/or medical device
- Understands business needs and impact of regulatory issues
- Excellent oral and written communications skills, with fluent in English. Proficiency in communicating strategic and tactical issues to management.
- Strong management skills
- Strong interpersonal skills and negotiation skills, with the ability to influence others without formal authority. Ability to function as an effective leader and team member.
- Sound analytical, conceptual, and strategic thinking skills. Ability to work independently, analyze complex problems, and proactively take initiatives.
- Demonstrated ability to consistently deliver against time-sensitive deadlines amid conflicting demands. Ability to prioritize and multitask.
- Commitment to achieve excellence with a strong work ethic and results orientation.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community? Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

**Duties and Responsibilities**:
Assist with the renewal of Product Registration and Licenses.

Assistant to the MRA Department

Assist on product label review, dossier review, promo materials and editing.

Administrative responsibilities, product filing in server, scanning of documents, filing of hard copies.

**Qualifications**:

- Graduate of Bachelor of Science in Pharmacy. With or without license.
- Willing to be assigned in Rockwell Makati
- Can work independently with less supervision
- Available to start anytime
- Fresh graduates are welcome.

**Job Type**: Temporary
Contract length: 12 months

**Benefits**:

- Flextime

Schedule:

- Day shift

Supplemental Pay:

- 13th month salary
- Overtime pay
- Yearly bonus

COVID-19 considerations:
All employees and visitors are required to wear mask, self declare and take temperature

Ability to commute/relocate:

- Makati City: Reliably commute or planning to relocate before starting work (required)

**Objective of the position**:

- To deliver Product Safety Service tasks to safeguard compliance to Philippine legislations and company directives to ensure business continuity and operations of businesses under care of Philippine Product Safety.

**Main Areas of Responsibilities**:

- Manage Regulatory Operations and Compliance Services
- Plan and align registration strategy with stakeholders by providing wholistic view of the requirement including data gap assessment and advise alternative approach to be able to agree on realistic timeline
- Develop and implement documented regulatory end-to-end process to establish efficient and systematic work structure.
- Champion Product Stewardship
- Implement applicable regulatory conditions such as but not limited to country label requirement; post notification requirements, post registration requirements and reporting requirements through engagement with internal stakeholders and functional supports to achieve full regulatory compliance
- Assist in regulatory monitoring focusing on area of specialization. Work with Product Safety Country Expert and relevant Operational Divisions in analysis and impact assessment for a provision of Management of Change.
- Drive regulatory advocacy with alignment to corporate BASF positions as appropriate in the local context through engagement with local industry associations and participation in relevant activities capacity building, workshops, etc.
- Provide periodic training and professional advice to stakeholders under area of specialization to ensure dissemination of updated information
- Data Gate Keeper
- Establish, manage, and maintain central documentation of submissions and relevant correspondence with authorities ensuring implementation of proper controls in CBI handling.
- Ensure appropriate and updated maintenance of country monitoring database and /or Operational Division Registration Database to provide visible status to stakeholders
- Ensure initiation of BASF Reference & Real Substances Data maintenance according to NSN to warrant appropriate country regulatory status in BASIS.

**Minimum Qualifications**:

- Bachelor’s Degree in Pharmacy with valid professional license. FDA Qualified Person in Industry Regulatory Affairs accreditation is an advantage.
- With 3-5 years of work experience in chemical or allied industry dealing with quality management or regulatory affairs. Experience in multi-national companies or large local companies with matrix organizational setup is preferred.
- Knowledgeable of organic and inorganic chemistry, polymer chemistry; analytical chemistry and quantitative analysis.
- Possess basic to in-depth knowledge of Philippine Chemical Legislations.
- With good analytical and problem-solving skills.
- Possess good organizational skills, a proactive mindset, and ability to multitask and prioritize work.
- Express self well in English both orally and in writing.
- Proficient in Windows and MS Office Applications.
- Demonstrate leadership, professionalism, and integrity at work.

SALARY RANGE: ₱22,000 - 25,000 | Depending on qualifications
WORK SCHEDULE: Monday - Friday | 8:00 AM - 5:00 PM br>WORK LOCATION: Makati | Willing to do Field Work

- At least 1 to 2 years of working experience in the same field / role