Sr Associate Regulatory Affairs
2 weeks ago
**Regional Specific Activities**
- Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements.
- Contribute to and execute the filing plan for their country where applicable
- Review source text for country labeling
- Review promotion and non-promotion materials
- Disseminate relevant information to team(s) as appropriate
- Participate in local regulatory process improvements initiatives
- Assist locally in Healthcare Compliance activities where applicable
- Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner
- Coordinating translation for local Regulatory submission.
**Collaboration**
- Collate, distribute and review Regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis.
- Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.
**HA Interaction**
- Under general supervision interact with local health and regulatory authorities for routine matters
**Knowledge and Skills**
- Regulatory principles
- Working with policies, procedures and SOP’s
- Knowledge of national legislation and regulations relating to medicinal products
- Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Knowledge of drug development
**Scientific / Technical Excellence**
- Team work
- Communication skills - both oral and written
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate and prevent potential issues
- Knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Understanding of regulatory activities and their touch points
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders.
Bachelor’s degree in **Pharmaceutical** and 2 years of directly related experience
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