Head of Drug Regulatory Affairs

4 The 4 essential elements that shape our culture: Inspired. Curious. Unbossed. Integrity. Our mission is to discover new ways to improve and extend peoples’ lives. Your passion to build, execute business plans to meet the sales goals, develop effective professional business relationships with Healthcare Professionals will help the world understand what these medicines do, why they matter and how Novartis is striving to reimagine medicine.
As Head of Drug Regulatory Affairs, you will direct the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports, provide strategic product direction to teams on interaction and negotiates evidence with regulatory agencies and interact and negotiate with regulatory agency personnel in order to expedite approval of pending registration and answers any questions.
You will also serve as a regulatory liaison on the project team throughout the product lifecycle, ensure rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices and serve as regulatory representative to marketing or research project teams and government regulatory agencies. You will be expected to provide advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

**Your Responsibilities**:
Your responsibilities include, but not limited to:

- Responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions. Provide input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partner with regions to align on regulatory strategy in order to fulfil business objectives. Implement RFP across assigned regions. -Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
- Facilitate preparation and finalization of briefing books and contributes to preparation of summary documents. Develop and implement plans for timely response to HA requests and coordinates responses.
- May serve as local HA liaison depending on location (e.g., FDA or EMA). Drive coordination, planning, and submission of dossiers in assigned regions worldwide. Review of global dossier summary documents.
- Develop and implement plans to avoid/minimize clock stops during submission review. Review, approve and submit Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- Review and submit Risk Management Plans. May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
- Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
- Contribute to and often leads the development of departmental goals and objectives.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- Degree in Life Sciences, Pharmacy, Biomedical or other related discipline.
- Leading large and/or diverse multi-functional teams
- Proven ability to develop trust-based relationships with key regional stakeholders
- Able to understand changing dynamics of Pharmaceutical industry
- Proficient and fluent in English and Thai (spoken and written), with good interpersonal and communication skills.
- Digital & Technology Savvy

**Why Novartis?**
769 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis

**Division**

Global Drug Development

**Business Unit**

REG AFFAIRS GDD

**Country**

Thailand

**Work Location**

Bangkok

**Company/Legal Entity**

NOV THA

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No