Regulatory Affairs Expertise Opportunity
3 weeks ago
Parexel is committed to delivering excellence in drug development.
- A minimum of 8 years' experience in handling life cycle management of approved drug products for ROW markets, including Tablets, Syrups, Ointments, and Nasal Sprays.
- Working knowledge of ROW regulatory guidelines, encompassing post-approval requirements.
- Familiarity with ASEAN markets' regulatory legislations would be an added advantage.
- Leverage expertise in planning, preparing, and delivering regulatory maintenance submissions from a global and/or regional perspective.
- Lead or contribute to minor labeling variations & safety labeling variations across ROW countries as per business needs.
- Experience in handling CMC & labelling related health authority queries.
- Collaborate closely with cross-functional members with aligned responsibilities and provide status updates to designated stakeholders.
- Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.
- Experience on Artwork Management Tools like Vista link would be an added advantage.
Key Responsibilities:
- Provide subject matter expertise in regulatory affairs.
- Develop and implement regulatory strategies.
- Liaise with cross-functional teams.
We Offer:
- An estimated salary of $120,000 - $150,000 annually.
- A dynamic work environment.
- Opportunities for growth and professional development.
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