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Associate Director/associate Principal Scientist
3 months ago
Organon is a Women's Health Company that believes in a better and healthier every day for every woman We are a passionate, global community of thousands dedicated to redefining the future of women's health.
Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We're looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you'll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a fortune 500 company with an international footprint that serves people in more than 140 markets.
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.
They 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 new product submissions and post-approval CMC supplements 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 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 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 firsttime 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.
- 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.
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