Job Functions1. Developing and implementing regulatory strategies for CMC aspects of pharmaceutical products2. Managing a team of regulatory CMC professionals and providing guidance and support for regulatory affairs activities3. Collaborating with crossfunctional teams to ensure regulatory compliance and timely product development
Job Requirements1. Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ years of experience in a relevant experience in regulatory affairs, with a focus on CMC aspects of pharmaceutical products.2. Strong attention to detail and ability to work independently.3. Ability to work in a fastpaced, dynamic environment and manage multiple priorities simultaneously.
Skills1. Strong understanding of regulatory guidelines and regulations related to CMC aspects of pharmaceutical products, including experience with regulatory submissions and interactions with regulatory agencies.2. Experience managing and leading a team of regulatory affairs professionals.3. Excellent communication and interpersonal skills, with the ability to effectively collaborate with crossfunctional teams.
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
The Director, Regulatory CMC will be responsible for overseeing the development and execution of regulatory strategies for Chemistry, Manufacturing, and Controls (CMC) aspects of our pharmaceutical products. The ideal candidate will have a deep understanding of regulatory requirements and guidelines related to CMC aspects of pharmaceutical products, as well as experience leading regulatory affairs activities for a biotech or pharmaceutical company.This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You’re a Regulatory CMC expert and leader who loves to solve difficult problems and are not discouraged by challenges. You’re a hands-on project manager who thrives in a fast-paced, dynamic environment. You’re well-organized, detail oriented, and take pride in your ability to rapidly analyze situations and judicious decisions. You’re collaborative by nature with uncompromising integrity. You’re conscientious and pay almost obsessive attention to detail, documentation and organization are second nature.
You thrive on the excitement of being a foundational member of a rapidly growing high visibility team.
What you’ll do
- Develop and implement regulatory strategies for CMC aspects of our pharmaceutical products, including preparing and submitting regulatory submissions to regulatory agencies.
- Interact with regulatory agencies to ensure compliance with regulatory guidelines and regulations related to CMC aspects of pharmaceutical products.
- Manage a team of regulatory CMC professionals and provide guidance and support for regulatory affairs activities.
- Collaborate with cross-functional teams to ensure regulatory compliance and timely product development.
- Keep up-to-date with current regulatory requirements and guidelines related to CMC aspects of pharmaceutical products.
- Provide strategic input on CMC aspects of product development and ensure that development plans meet regulatory requirements.
- Manage and oversee CMC-related activities for regulatory inspections and audits.
- Participate in the development and implementation of regulatory policies and procedures related to CMC aspects of pharmaceutical products.
Qualifications
- Post Graduate degree with 10+ years of experience or a Bachelor's degree with 12+ years of experience in a relevant experience in regulatory affairs, with a focus on CMC aspects of pharmaceutical products.
- Strong understanding of regulatory guidelines and regulations related to CMC aspects of pharmaceutical products, including experience with regulatory submissions and interactions with regulatory agencies.
- Experience managing and leading a team of regulatory affairs professionals.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
- Ability to work in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
- Strong attention to detail and ability to work independently.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
The expected salary range for this role is $213,000 to $232,750 depending on skills, competency, and the market demand for your expertise.Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Life at Eikon Therapeutics
Thrive Here & What We Value1. Passion for innovation and improving patient outcomes. | 2. Daily subsidized lunch program when onsite. | 3. Generous paid time off and holiday policies. | 4. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 5. Enhanced parental leave benefit. | 6. Weeklong summer and winter holiday shutdowns. | 7. Mental health and wellness benefits.</s> | Equal Opportunity Employer | Generous Benefit Programs | Daily Subsidized Lunch Program</s> | Eikon Therapeutics is committed to creating a positive and inclusive workplace culture that values collaboration, innovation, and creativity. | The company offers generous benefits programs, including 401k plan with company matching, medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies. | Daily subsidized lunch program when on-site | Enhanced parental leave benefit</s> | 1. Innovative and forwardthinking approach to drug discovery | 2. Emphasis on collaboration and teamwork | 3. Focus on creating novel treatments for lifethreatening diseases | 4. Commitment to equal opportunity employment | 5. No thirdparty agencies or firms currently being considered</s> | 1. Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for lifethreatening diseases. | 2. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | 3. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching, Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), Mental health and wellness benefits, Weeklong summer and winter holiday shutdowns, Generous paid time off and holiday policies, Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies, Enhanced parental leave benefit, Daily subsidized lunch program when on-site.</s> | 2. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | Eikon Therapeutics is committed to discovering novel treatments for life-threatening diseases using groundbreaking innovations from its founders. | The company's discovery platform is built on revolutionary technology at the intersection of Chemistry, Engineering, Computation, and Biology. | Eikon values collaboration, agility, and operational excellence in building and leading in-house clinical operations study management teams.</s> | Mental health and wellness benefits</s> | 1. Eikon Therapeutics is an equal opportunity employer and will consider all qualified applicants for employment. | 2. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 3. Daily subsidized lunch program when onsite. | 4. Weeklong summer and winter holiday shutdowns. | 5. Generous paid time off and holiday policies. | 6. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 7. Enhanced parental leave benefit.</s> | Eikon Therapeutics is committed to creating an inclusive culture that values diverse perspectives, experiences, and backgrounds. | The company offers generous benefits programs, including medical, dental, and vision insurance, mental health and wellness benefits, paid time off, holiday policies, life/AD&D Insurance, parental leave benefit, and daily subsidized lunch program when on-site.</s> | 3. Focus on making a positive impact on patients' lives through novel treatments for lifethreatening diseases | 4. Supportive and inclusive work environment | 5. Opportunities for professional growth and development</s> | 1. Eikon Therapeutics is committed to creating a diverse and inclusive workplace culture that values collaboration, innovation, and excellence. | 2. The company offers generous benefits programs, including 401k plan with company matching, medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies. | 3. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.</s> | 1. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 2. Generous paid time off and holiday policies | 3. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 4. Enhanced parental leave benefit | 5. Daily subsidized lunch program when onsite</s> | 3. Focus on improving patient outcomes through novel treatments | 4. Commitment to scientific excellence and integrity | 5. Support for professional development and growth</s> | Generous benefit programs, including 401k plan with company matching, medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) | Daily subsidized lunch program when on-site</s> | 1. Dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment | 2. Generous benefit programs, including 401k plan with company matching, medical, dental, and vision insurance, mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%), enhanced parental leave benefit, daily subsidized lunch program when onsite.</s> | Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. | Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), mental health and wellness benefits, weeklong summer and winter holiday shutdowns, generous paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies, enhanced parental leave benefit, daily subsidized lunch program when on-site.</s> | 2. Collaborative and supportive environment | 3. Emphasis on teamwork and communication | 4. Focus on making a positive impact in the world through novel treatments for lifethreatening diseases | 5. Commitment to equal opportunity employment</s> | 1. Equal Opportunity Employer | 5. Enhanced Parental Leave Benefit</s>
