Regulatory Specialist

4 weeks ago

Singapur, Singapore Careers@Gov Full time
Description Summary
The Health Products Regulation Group (HPRG) of HSA ensures that medicines, innovative therapeutics, medical devices and health‐related products are wisely regulated and meet appropriate safety, quality and efficacy standards. HPRG contributes to the development of biomedical sciences in Singapore by administering a robust, scientific and responsive regulatory framework.

The Innovation Office and Clinical Trials Branch (IOCTB) of HPRG is responsible for the regulation of clinical trials in Singapore. In addition to the evaluation of clinical trial applications, the Innovation Office provides early regulatory consultations to companies and researchers to facilitate efficient innovative therapeutic product development.

We are looking for an experienced and qualified individual to join the Innovation Office and Clinical Trials Branch. The Senior / Regulatory Specialist provides/leads the provision of regulatory and scientific advice to stakeholders, and conducts/leads the conduct of the scientific review of data to support the safe use of investigational products in clinical trials, to support innovative product development and to support product approval in Singapore. The individual is also expected to contribute in regulatory policy and guidance review and development, efficient and effective operations, and effective implementation of projects in the branch. The individual is expected to keep abreast of scientific advances and contribute to networking, regulatory collaborations/partnerships at national, regional and international levels.

Core r e sponsi bil i ti es in c lud e :
  • Provi d e / le a d r eg u la t ory and s c ien t i f i c adv i ce t o s t akeholders as part of t h e Innovation Of f i c e to f acilitate ef f i c i e n t d e v e lopm en t o f i n n ova t ive therapeu t i c pro d uc t s.
  • Co nd u ct /l e a d s c i e n ti fic r e v iew and provi d e re c o mm e n dat i o n s on c l i n i cal t rial ap p l i c a t i o n s a n d n e w d ru g a p pl i c a t i o ns i n S i ng apo r e .
  • C o nt r ib u t e t o st akeh o l der tr ai n i ng , co m mu ni c at io n a n d engageme n t
  • C o nt r ib u te / l e a d r egu l a to r y p o l i c y a n d g ui da nc e r ev iew a n d  d e ve l o pm e n t, ef f i c i e n t a n d e ff e c ti v e o p era t io n s, e f fec t ive i mp lem e n t a t i on of p r oj ec ts.
  • Keep abreast of emerg i ng scien t ific advances rel a t ing t o no ve l t e ch nol o gie s a n d pr o du c t t y pe s w i t h a v iew to provide rele v ant s t r ategic and sci e n tific inputs to ensure regulatory fr a mework is r e sponsive to e m ergi n g d e ve l o pm e n ts
  • R e p r e s e n t S i ng a p o r e’s i n te r ests and c ont r i bu t e to n e tworking, d ev e lop m ent of h a r m on i s e d t e ch n i c al gu i d anc e , re g u la tor y col labo r a tio ns a n d p a rtner s hi ps at n a t i ona l , regional a nd i n ter n a t io n al l e ve l s.

Job Requirements

  • Possess knowledge and experience in related scientific disciplines, e.g., Medicine, Pharmacy, Pharmacology, Toxicology, Immunology, Infectious Diseases/Microbiology, Oncology, Genomics/Precision Medicine, Cell, Tissue and Gene Therapies, Biomedical/Biological/Health Sciences

Experiences

  • 2 ‐ 10 year s ’ r egu la t ory a n d/or sc i e nt ific e xp eri e n c e in t h e no n‐c l i nic a l, qu al it y a n d / o r cl i n i c al deve l o p men t of therapeu t i c produ c ts i n the p h ar m a c eut i cal i n d u s tr y or ac a d e m i a
  • K now le dg e o f th e d r ug de ve lo p m e n t pr o c e ss, reg u l at o r y req u ire m ent s, G C P (G o od C l in i c al P r a ct i ce ) gu i del ines a nd o th er r e lev a n t d r u g deve l op m ent s c i en tific gu i d e li n es
  • E x p e r i ence a nd e x p e r tise i n sci e ntific dis c iplines r elevant to d ru g de v e l o pm e n t , s u c h a s cl i n ical p h a r m aco l ogy, to x i c ology, i mm u n ology, m ole cu lar b i ology, p r e c i s i o n m e di c i ne , r e g u l a t o r y scie n ce , m o de l‐i nfo r me d d r u g d evel o pm e n t , ad a p t ive / i nn o vativ e tr i a l de si g n and s t at i s t i c s would b e an a d va nt age.
  • Fa m i l iari t y with th e loc a l b iom e d i c a l sc i e n c e s lan d scape w o u ld b e an a d v a nt a g e

P er s o nal a ttribut e s

  • Cr i t ic al and str a t e gic t hi n ker w i th good a n a l yt i cal skil l s. A ble to an a lys e , in t e rp r e t a n d c o m m un i c a t e t ec h n i c al d a t a ef f e c tively.
  • D e mons tr ates ability to f a c ili t ate o r lead mee t ings, make ef f e c tive presentati o n s, o rga niz e forums a n d e ng age collaboratively and e f fec t ive l y with i n te r n al and exte r nal s t a k e h ol d ers
  • Ef f ective oral and writt e n c o mm u n i c a t i o n s k i l l s. A b l e t o com mu n i c a t e con fid ent ly a n d di p l o m at i c a l l y w i t h v a r i ous s t a k e h ol d ers
  • Able t o eng a ge and work e f fe c tively w i t h ex t ernal d o main e xp erts wh e r e nec e ssary
  • A b i l i t y t o l e a d pr o j ec t s t o d e l iver r e s u l ts
  • Sel f ‐d i rect e d le a rner , pr o act i v e a n d able t o wo r k in a f a s t ‐ pac e d envir o nm e n t
  • A b le t o p r io r i tiz e wo r k ac c o r d in g t o ti m el i ne s.

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