- This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include preparation and compilation of submission/documentation for specific projects working as or working with the Regulatory CMC Lead and key stakeholders, primary contact for affiliates on Regulatory CMC activities in the assigned regions and managing of routine and non-routine Health Authority interactions as delegated. Depending on the stage of development and complexity of the program, this role can be a Regulatory CMC Lead for early stage development programs or working with the Regulatory CMC Lead for late stage development or commercial programs. The Regulatory CMC Lead is the primary global contact for Regulatory CMC activities, as delegated.
- This candidate must have proven leadership and abilities to work cross-functionally and across cultures. Strong communication, Regulatory CMC knowledge and interpersonal skills are required.
- Providing strategic and operational Regulatory CMC expertise and support in cross-functional teams, as required, and working flexibly within and across regions to provide broad operational support to ensure the delivery of project/products and business objectives.
- Preparation and delivery of CMC Regulatory operational plans for products in the assigned regions and supporting the preparation and delivery of regulatory submissions (including IND/IMPD/CTAs/MAAs)
- Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
- Writing and / or Review of regional and global CMC submission documents and responses to Health Authority questions
- Managing CMC aspects of routine and non-routine Health Authority interactions including issue resolution and negotiation of approvals, as delegated.
- Monitoring changes in the Regulatory CMC environment to support and advise key stakeholders and teams.
- Providing input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy.
- Coordinating and completing regulatory assessments of CMC changes in the designated systems
- Responsible for assuming responsibilities from the Team Lead or Global Regulatory CMC lead, as agreed and delegated and maintaining open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions.
- Responsible for leading or assisting in delivery of project assignments supporting business needs e.g. representation of Regulatory CMC on cross functional work streams
- Responsible for leading or assisting in delivery of Regulatory CMC initiatives and the development of Regulatory CMC standards and SOPs, as assigned.
- Ensure that appropriate records are maintained in the designated system for submission in assigned regions
- At least 3-5 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 3 years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, or quality assurance/control or related technical field.
- Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products (biological, oligonucleotide, and/or chemical entities)
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and/or post-approval products
- Experience of direct communication and negotiation with regulatory agencies on CMC matters
- Knowledge of GMP requirements and standard systems (e.g. change management systems)
- Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
- Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.
- Ability to influence cross-functional stakeholders to ensure execution of optimal RegCMC strategy
- Demonstrated inclusive leadership and emotional intelligence, along with verbal and written remote working communication abilities.
- Demonstrated strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.
- Demonstrated competency in operations, planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
- Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.
- Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.
- One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
- ClearlyRated Client Diamond Award Winner
- One of the Largest Certified MBE Companies in the NMSDC Network
- Advanced Tier Services partner with AWS and Gold with MS
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Regulatory Affairs Manager III - Cambridge, United States - Innova Solutions
Description
Innova Solutions is immediately hiring for a Regulatory Affairs Manager IIIPosition: Type: Full Time, Contract
Duration: 06 Months (Possibility to extend)
Location: 100% Remote or hybrid (Cambridge, MA or RTP)
Note: 100% Remote or hybrid (Cambridge, MA or RTP)
Job Description:
High-Level Description:
Regulatory skills
Thank you
Aravind Kumar L K
Lead - Recruitment
PHONE:
EMAIL:
PAY RANGE AND BENEFITS:
Pay Range*: Between $84.00 to $86.00 Per Hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
