Associate Director/associate Principal Scientist

6 months ago

Cramlington, United Kingdom Organon Full time

**Welcome to our Team**

Reporting to the CMC Senior Principal Scientist, International CMC (EU/EEMEA), the successful **Associate Principal Scientist **will be accountable for assessment of changes for regulatory impact, development of regional CMC strategy in EU/EEMEA, preparation of CMC documentation and execution of regional post-approval CMC supplements and new product registrations for the entire company portfolio of small molecule, biologic and biosimilars, serving as a link between Country Regulatory Affairs (CRA) team requirements and global CMC strategy to ensure right first-time submissions to Health Authorities.

You will work closely with CMC Product Leads to ensure that key CMC projects are successfully prosecuted in the region.

**What you will do**:
Bring energy, knowledge, innovation, and leadership to carry out the following:
The incumbent will be accountable for implementing regional CMC strategy for international markets for CMC life-cycle submissions with a focus on achieving right-first-time submissions, including the following activities:

- Working collaboratively with Global CMC Regulatory Affairs 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 products life-cycle.
- 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 EU/EEMEA 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 promote right first-time submissions.
- Ensure high quality and timely responses to Regulatory Agency questions in EU/EEMEA markets and fulfilment of regulatory commitments to Regulatory Agency deadlines.
- Sponsor 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.

**What skills you will need**:
In order to excel in this role, you will more than likely have:

- Possess a Bachelors or Master’s Degree in chemistry, pharmacy, biology or a related science, with a minimum of 5 years of experience in the pharmaceutical industry, in Regulatory Affairs and/or Technical Regulatory.
- Minimum of 3 years’ experience in CMC Regulatory Affairs for biotechnology (preferred) or pharmaceutical products.
- Experience in Regulatory Affairs for the EU/EEMEA markets, with a focus on Regulatory CMC requirements for small molecule/biologic/biosimilar products, development, manufacturing and/or quality assurance.
- Direct Health Authority experience would be an advantage.
- Demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
- Ability to influence and work both freely and collaboratively in a team structure.
- Proven ability to work well under pressure.

**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**

**Employee Status**:
Regular

**Relocation**:
No relocation

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

10%

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R520577

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