BioCare Manufacturing (M) Sdn Bhd is looking for new potential candidates to fill in for REGULATORY AFFAIRS MANAGER position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- Coordinate and participate in preparation of different types of regulatory submission (e.g. dossier, variations, scientific advice submissions) to competent authorities for approved and development products.
- Ability to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner with excellent written and interpersonal communication skills.
- Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors.
- Ensure that submissions are of high quality, meet all regulatory requirements and are in compliance with corporate goals and directives.
- Provide regulatory feedback in project teams
- Participate in contacting competent authorities for respective projects/products and interact with internal departments.
- Reviews scientific information to ensure the data is complete, sound, logical, and supports the program goals.
- Interprets regulations and ensures regulatory compliance. · Exercises good judgment within company policy and health authority regulations.
- Keeping up to date with changes in regulatory legislation and guidelines
- Writing comprehensible, user-friendly, clear product information leaflets and labels
- Candidate must possess at least Bachelor's Degree/Post Graduate in BioTechnology, Chemistry, Science & Technology, Pharmacy, Pharmacology or equivalent.
- At least 4 Year(s) of working experience in the related field is required for this position.
- Significant experience in both pharmaceutical and device regulatory affairs required.
- Previous experience with combination product regulatory strategy and/or execution is strongly preferred.
- Minimum 3 years experience in product registration
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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