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Regulatory Affairs Manager: Graduate Area of Work
Regulatory affairs managers in healthcare and pharmaceuticals work as a bridge between private companies and regulatory authorities.
Acting as vital links between manufacturers, service providers, regulatory authorities and the public, regulatory affairs managers play a pivotal role in the pharmaceutical sector. Graduates holding this role are responsible for the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products.
Regulatory affairs is a specialised area of work that ensures the safety and efficacy of products. Graduates looking to work in regulatory affairs will become the eyes and ears of a company when it comes to corporate responsibility. Other job titles for this role include compliance officer, regulatory affairs officer and compliance specialist.
Graduates who are looking to join this area of work should expect to have a great deal of responsibility. Many pharmaceutical firms hire regulatory affairs managers who are skilled and responsible to ensure no mistakes are made that may harm consumers or the reputation of the firm.
Some of the key duties of a graduate role as a regulatory affairs manager involve the following:
- Studying scientific and legal documents
- Maintaining familiarity with company product ranges (as they change)
- Meeting compliance standards and regulations set by the relevant regulatory bodies
- Outline requirements for labelling, storage and packaging
- Offering advice about company policies, practices and systems
- Planning, undertaking and overseeing regulatory inspections and product trials
- Obtaining marketing permission
- Liaising and negotiating with regulatory authorities
Graduates starting out at an entry level typically start as regulatory affairs assistants before progressing into an officer’s role or a managerial role.
Required skills and qualifications
Not all companies in this sector are prepared to recruit and train graduates in this area of work. Given the specialist nature of this role, employers prefer to employ experienced individuals for the role. Hence, to successfully attract employers to hire you as a graduate, you will need prior experience in other relevant areas, such as research or quality assurance.
You must also have the relevant degree to enter this area of work, such as chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science. Having a relevant postgraduate qualification will also put you at an advantage.
Key skills that are sought after by employers in the pharmaceutical sector, particularly for a role in regulatory affairs, include IT, negotiation, analytical and interpersonal skills. Graduates should also be good at time management and problem-solving. A strong background and understanding in the relevant legal, scientific and manufacturing areas are also necessary for graduates to succeed in this field.
Pros and cons
A role in regulatory affairs can be challenging because it requires managers or officers to maintain high levels of accuracy, meet strict deadlines and negotiate successfully as a mediator between pharmaceutical firms and regulatory bodies.
However, the outcome of your efforts influence decisions at high levels. Your work directly relates to the safety of the public and can influence whether or not a product should be rolled out. Graduates who are passionate about corporate social responsibility may find this a rewarding aspect of the job.