Regulatory Affairs Consultant

**Accountability / Scope**
- As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration.
- Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop approach to solutions.

**Major Responsibilities**:

- Possess well developed skills in supporting development of product registration dossiers, submission, progress reports, deficiencies, and amendments.
- Support teams to develop regulatory submissions strategy and update strategy based upon regulatory changes.
- Partnership with affiliates to support regulatory agency interactions to expedite approval of pending registration.
- Participates/ Awareness on project plans, regulatory submission strategy, any risks management.
- Partner with other regulatory functions for smooth project transition and launch.
- Support review of change controls to determine the level of modifications and consequent submission requirements.
- Support pulling reports, metrics related to submissions and approvals.
- Offers country specific regulatory support (INVIVA).

**Requirements Include**:

- Prior experience (3-4yrs) and bachelor’s degree in health care or science.
- Good English skills.
- Experience with Veeva Vault, not mandatory.
- Good understanding and working experience in different regulatory environment in Colombia.
- Decision Making/ Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Influence stakeholders on technical solutions.
- Adaptable in cultural and political diversity.
- Capacity to learn and challenge status quo.

LI-REMOTE

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