Associate Director Regulatory Affairs Job at Amgen (Hyderabad)

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

In this vital role you will support products in the Obesity Therapeutic Area. Gl...

Location

United States

Salary:

220356.00 - 269853.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of regulatory experience in biotech or science
Master’s degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science

Job Responsibility

To lead GRTs within Amgen’s GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Director, Regulatory Labeling

Beam is seeking a Director of Regulatory Affairs – Advertising, Labeling, and Pr...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS required
an advanced degree (i.e. MS, PharmD, PhD, MD) is a plus
A minimum of 6 years of experience working in Regulatory Affairs Advertising, Labeling, and Promotion
ideally 15 plus years in the biotech industry with at least 8 years in regulatory affairs
Record of success with interactions with Regulatory Agencies and Health Authorities as part of label negotiations and label updates
Comprehensive knowledge of US and global regulatory procedures and practices
Extensive experience with regulatory documents and filings (IND, CTA/IMPD, BLA, MAA, PIP)
Strong strategic thinking and problem-solving skills
Experience in representing programs to internal and external stakeholders
Ability to develop collaborative working relationships internally as well as externally with physicians, expert consultants, and contracted vendors

Job Responsibility

Lead the creation, review, and approval of critical regulatory labeling documents including Core Data Sheet and Regional Labels for Beam hematology programs in alignment with Target Product Profiles
Lead labeling negotiations between Beam and health authorities as part of marketing authorization applications
Create regulatory labeling processes and associated SOPs, Work Instructions, and any other required documentation
Represent Regulatory Affairs as part of the Promotional Review Process
Incorporate the evolving global regulatory requirements and guidance's with respect to gene editing and gene therapy, rare disease, and prescription drug labeling
Provide innovative regulatory approaches, solutions and guidance to cross-functional teams while mitigating regulatory risks
Guide and assist on the planning, preparation, writing and submission of regulatory documentation
Manage project plans and timelines to ensure all projects are prioritized appropriately and milestones and goals are met on time
Provide regulatory due diligence as required
Supervise and mentor direct reports

Fulltime

Associate Director Biostatistics

Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN)...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 12+ years of post-graduate statistical experience in the pharmaceutical industry or medical research
Master’s degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 16+ years of post-graduate statistical experience in the pharmaceutical industry or medical research

Job Responsibility

Provide sound statistical guidance to clinical development, reimbursement, and medical affairs
Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents
Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies
Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings
Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives
Execute biostatistical strategies across the product lifecycle, from early development through post-marketing
Provide consultancy and training to colleagues across R&D
Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance
Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees)
Drive technology adoption leveraging AI capabilities to streamline statistician’s work

What we offer

Vast opportunities to learn and develop within our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Associate Medical Director

Associate Medical Director, Oncology. ICON plc is a world-leading healthcare int...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Medical degree (MD) required
Board certification preferred in oncology/haematology
Minimum of 3 years of experience in clinical research or medical affairs within the pharmaceutical or biotechnology industry
Strong understanding of clinical trial design, execution, and regulatory requirements
Experience in immune oncology
Excellent communication and relational skills
Demonstrated leadership and problem-solving abilities

Job Responsibility

Collaborating with cross-functional teams to design clinical development plans and study protocols
Providing medical oversight and guidance throughout the lifecycle of clinical trials
Ongoing medical review of data, supporting Safety Review Committees
Interpreting complex medical and clinical trial data to support decision-making and regulatory submissions
Contributing to the development of scientific publications, presentations, and regulatory documents
Building and maintaining relationships with investigators, key opinion leaders and regulatory authorities

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits

Director, Regulatory Affairs – Americas & ANZ

As Director Regulatory Affairs (Americas & ANZ), you set and lead the regulatory...

Location

United States

Salary:

154000.00 - 230000.00 USD / Year

ResMed

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs or equivalent
advanced/regulatory certification (e.g., RAC) highly desirable
Minimum 10 years of regulatory affairs experience in medical devices (Class II/III, SaMD, combination products), with significant experience in Americas markets (US, Canada, LATAM)
At least 3–5 years in a leadership role managing regulatory teams and interfacing with cross-functional business stakeholders
Deep knowledge of MD regulatory frameworks: FDA (21 CFR, QSR), Health Canada, ISO 13485/MDSAP, LATAM device regulations — demonstrated ability to navigate complex, multi‑jurisdictional regulatory environments
Strategic mindset and business acumen: ability to translate business goals into regulatory strategy, balance compliance and commercial objectives, drive enterprise‑level initiatives
Excellent stakeholder management, communication, influencing, and negotiation skills (internal leadership, external authorities, business partners)
Fluent in English, with Spanish and/or Portuguese strongly preferred for LATAM coverage
Willingness to travel across Americas region
flexible to address regulatory or business needs globally as required

Job Responsibility

Define and lead the Regulatory Affairs roadmap for Americas in alignment with global corporate strategy and regional Revenue ambitions
Represent Regulatory Affairs in regional leadership, commercial planning and strategic cross-functional meetings including but not limited to Revenue, Marketing, Supply Chain, Operations, Quality, Legal
Lead strategic high-complexity/ high-risk regulatory projects
Active member of the RA Leadership Team fostering collaboration and contributing to build the future of the Regulatory Affairs function
Oversee the preparation & submission of regulatory filings (including both product & facility licensing/registration) within Americas for all class and type of Products
Anticipate regulatory trends and shifts (US, Canada, LATAM, ANZ), shape proactive strategies (policy monitoring, engagement with regulators, participation in industry associations), influence external regulatory landscape as appropriate
Drive global-to-regional alignment: ensure Americas regulatory approach aligns with global RA standards while adapting to local market needs
propose harmonization initiatives for labeling, documentation, submission processes across region
Ensure robust compliance framework for Americas: audit readiness (MDSAP, ISO 13485, FDA QMS compliance), risk management, regulatory intelligence dissemination, crisis readiness (e.g., regulatory actions, recalls)
Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands

What we offer

comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Flexible Time Off (FTO), receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Fulltime

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
Thorough understanding of Health Canada, FDA, and EMA regulations
Ability to efficiently oversee independent contractors and vendors
Skilled regulatory writer with effective oral communication skills
Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
About 12 years of relevant work experience

Job Responsibility

Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
Overseeing the preparation of responses to regulatory authority queries
Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship

Fulltime

Senior Manager, Government & Regulatory Affairs

GEICO is seeking an accomplished government relations professional to join our t...

Location

United States , Sacramento

Salary:

158875.00 - 248050.00 USD / Year

Geico

Expiration Date

Until further notice

Requirements

Juris Doctor (JD) degree from an accredited law school and admission to practice law in at least one U.S. jurisdiction highly preferred
Minimum 10 years’ relevant government affairs experience with knowledge of insurance regulation, regulatory law, or related public policy fields, preferably within property and casualty insurance
knowledge of auto insurance a plus
Proven experience, with a track record of successfully developing and implementing regulatory and legislative strategies
Deep knowledge of U.S. insurance regulatory systems, including state insurance departments and the National Association of Insurance Commissioners
Strong analytical skills, with the ability to translate complex regulatory developments into actionable business strategies
Strong verbal and written communication and presentation skills tailored to different audiences
Exceptional communication, negotiation, and interpersonal skills, with a collaborative approach to working within cross-functional teams
Ability to balance independent legal judgment with teamwork and enterprise-wide policy development processes
Ability to articulate GEICO’s positions in an impactful and persuasive manner to decision makers and industry leaders and to offer strategic advice on complex legislative and regulatory issues to business professionals

Job Responsibility

Policymaker Engagement: Build and maintain a strong network of key policymakers, including state legislators, heads of relevant executive agencies and their staff, industry members, policymakers (NAIC and NCOIL), and trade associations to efficiently and effectively advocate GEICO’s positions in assigned states. Develop comprehensive strategic plans to facilitate effective engagement with legislative and regulatory stakeholders to achieve GEICO’s business objectives
Regulatory & Legislative Analysis: Review and evaluate impactful insurance regulatory/ legislative proposals, working in close collaboration with relevant Government & Regulatory Affairs colleagues and other internal stakeholders. Ensure that GEICO's business units and corporate functions remain informed about critical and emerging issues
Strategic Monitoring & Reporting: Proactively identify evolving regulatory and legislative trends and effectively communicate relevant insights and potential risks to the Government & Regulatory Affairs team, business units, and senior management to support informed, enterprise-wide strategic decision-making
Strategic Support: Work with the Director of Public Policy and business stakeholders to develop policy positions, strategy, responses/draft language
prepare for legislative and regulatory interactions
and support company’s strategic initiatives
Coalition Building: Support the strategic implementation of GEICO’s key public priorities through coalition building and coordination of external resources. Maximize outside firms and association memberships to successfully advocate GEICO’s priorities. Develop and execute effective and efficient political contributions strategies in assigned states, in consultation with business, to enhance GEICO’s policy agenda
Additional Duties: Assume other regulatory or legislative responsibilities as priorities evolve

What we offer

Comprehensive Total Rewards program that offers personalized coverage tailor-made for you and your family’s overall well-being
Financial benefits including market-competitive compensation
a 401K savings plan vested from day one that offers a 6% match
performance and recognition-based incentives
and tuition assistance
Access to additional benefits like mental healthcare as well as fertility and adoption assistance
Supports flexibility- We provide workplace flexibility as well as our GEICO Flex program, which offers the ability to work from anywhere in the US for up to four weeks per year

Fulltime

Associate Director Regulatory Affairs

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 18, 2025

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