Regulatory Affairs Specialist (FSP)

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.