Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Duties and responsibilities

Ensuring that products, operations, and business transactions follow all relevant legal and internal rules

Preparing and submitting documentation to regulatory authorities for approvals and licenses and ensuring that vitamins & minerals containing products abide by the requirement in food stipulated by government

Supporting and coordinating with various departments during the development of a product to ensure regulatory compliance including the cross border products

Assisting with the organization of regulatory inspections and conducting internal audits whenever needed

Keeping up to date with changes in regulatory legislation and guidelines and being able to apply it and promulgate it within the corporation

Advising and guiding the team and other relevant departments on regulatory requirements and changes

Reviewing product promotional materials, labelling, batch records, specification sheets, quality control checks and validation protocols for compliance with regulatory standards

Maintaining comprehensive electronic and paper-based records of all regulatory affairs activities

Researching and collecting information about new and existing regulations and guidelines

Years of experience required:

1- 2 years post graduate experience with prior studies in life sciences degree, e.g. Biology, Biochemistry

Basic attributes:effective communication skills, detail-oriented, being meticulous and willing to try out new projects. Other qualities include:

1. Effective Communication: The ability to convey complex regulatory requirements clearly to diverse audiences, both internally and externally.

2. Teamwork: Working collaboratively across departments like R&D, QA, and marketing to ensure compliance and successful product submissions.

3. Adaptability and agility: Staying flexible in a field where regulations and priorities can change rapidly.

4. Critical Thinking: Evaluating challenges thoughtfully and proposing logical solutions.

5. Time Management: Prioritizing tasks and meeting tight deadlines for regulatory submissions.

6. Ethical and Compliance Judgment: Upholding integrity in ensuring the close adherence to regulations and standards.

Required profile