Postúlate en Kit Empleo: kitempleo.com.co/empleo/1as8xl

**The Position**

Appointment to this position will be on local salary and benefits package.

**Responsibilities**

The incumbent will be accountable for implementing regional CMC strategy for international markets for post-approval CMC supplements and new product submissions with a focus on achieving right-first-time submissions, including the following activities:
Working collaboratively with Global CMC RA Product Leads, the team will ensure right first-time submissions, high approval rates, on target launches and successful implementation to maintain patient supplies throughout the product lifecycle.

Ensure that the regional CMC regulatory strategy is aligned with the global regulatory strategy, Franchise portfolio, commercial and operational strategies and issues impacting product approval, launch or patient supplies will be appropriately escalated to CMC Regulatory Affairs Management.

Act as Regulatory CMC SME in regional post approval requirements, ensure awareness of regional regulatory policy trends and maintain/update the regulatory intelligence repository for regional markets, including communicating proactively with Global CMC Product Leads on regional registration requirements, new legislation and guidance and providing timely update of the CMC change management systems to support right first-time submissions.

Ensure high quality and timely responses to Regulatory Agency questions in regional markets and fulfillment of regulatory commitments to Regulatory Agency deadlines.

Support product compliance by ensuring local registrations and lifecycle management align with product manufacturing details.

Drive continuous process improvement activities within the organization and participate in forums to ensure efficient processes and best practice.





Influence CMC initiatives by internal and external engagement including trade associations and regulators to pursue priority advocacy plans impacting the business.

**Required Education, Experience and Skills**

He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.

**Preferred Education, Experience and Skills**

Ability to influence and work both independently and collaboratively in a team structure.

Proven ability to work well under pressure.

OCMC

**Secondary Job Description**

**Who We Are**:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Annualized Salary Range (Canada)**

**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**

No Travel Required

**Adaptable Work Arrangements**:
Remote Work

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R536466

Postúlate en Kit Empleo: kitempleo.com.co/empleo/1as8xl

📌 Sr. Scientist, Regulatory Affairs -chemistry Manufacturing & Controls (Cmc) (Bogotá)
🏢 Organon
📍 Bogotá